Sample proposal health weight loss program
For the participants in the group receiving in-person support, we encouraged but did not mandate participation in group sessions and gave these participants the option of maintaining individual contact by phone rather than in person. In the group receiving remote support only, the median number of completed phone calls was 14 in the first 6 months and 16 for the remainder of the trial. 8% in the control group, 41. e. entries. g. Participants in the two intervention groups were encouraged to lose 5% of their baseline weight within 6 months and to maintain the reduced weight until the end of the study. In general, the eligibility criteria for the trial were less stringent than those typically used in efficacy trials. CrossRef 8 Y. (2016) Weight change among people randomized to minimal intervention control groups in weight loss trials. For both interventions, primary care providers reinforced participation at routinely scheduled visits. The proposal should include a list of references and a timeframe. First, in contrast with previous interventions involving only telephone- or Web-based interventions, the weight loss achieved in the group receiving remote support only was substantial and similar in magnitude to that achieved in the group receiving in-person support in addition to remote support. (2016) A randomised controlled trial of a lifestyle behavioural intervention for patients with low back pain, who are overweight or obese: study protocol. Endocrinology and Metabolism Clinics of North America 45:3, 565-580. Table 1 Table 1 Features of Both Interventions. Lustig, Michael Acree, Jean Kristeller, Michael Cohn, Mary Dallman, Patricia J. Manson, I. Kamper, Christopher M. The topics covered included behavioral theory and strategies, basic nutritional and exercise guidelines, motivational interviewing techniques, and study procedures, including use of the intervention Web site. At each point in its design and implementation, we tailored our approach to reflect the setting — namely, primary care practices. Means were modeled as a function of the group assignment and study visit (at baseline and at 6, 12, and 24 months). Irvin, Robert M. 15-17 Motivational interviewing was the primary approach to interactions with participants. The intervention without in-person contact provided patients with support by means of the telephone, the Internet, and e-mail. Participants in both intervention groups were offered weekly contact with coaches during the first 3 months (nine group sessions and three individual sessions for participants receiving in-person support, and 12 weekly calls for those receiving only remote support). Jebb, Anthony Kafatos, Angeliki Papadaki, Andreas F. Kimminau, Allen Greiner, Byron Gajewski, Terry Huang, Michael G. Head, D. The percentage of participants whose weight at 24 months was at least 5% below their baseline weight was 18. CrossRef 26 Ghanshyam Palamaner Subash Shantha, Anita Ashok Kumar, Vimal Ravi, Rohit C. 5%) at 24 months. Ross, Rena R. Article Activity 225 articles have cited this article Article Obesity is an important and growing public health problem around the world. CrossRef 16 Emily Brindal. To assess fidelity to the protocol and to promote motivational interviewing techniques, a case-management team observed the coaches and provided feedback monthly for the first 3 months of the study and quarterly thereafter. Design considerations and rationale of a multi-center trial to sustain weight loss: the Weight Loss Maintenance Trial. An institutional review board approved the trial, as did an independent data and safety monitoring board. The trial also had several strengths, including a diverse population and high rates of adherence and follow-up. Ho. Washington, Nancy Brahm. Sample Research Proposal Resident: John Smith, PGY2 Research Mentor: Jane Doe, MD, Section of General. (2016) A design and focus group evaluation of dietary choices tools for an underserved population. The National Heart, Lung, and Blood Institute and Healthways had opportunities to comment on the manuscript. CrossRef 36 Tressa McMorris, Gary Sweet, Christopher J. CrossRef 6 Amanda Williams, John Wiggers, Kate M. Micale. The enrollment process involved a Web-based contact, an in-person visit during which baseline data were collected, and a second in-person visit at which participants were notified of their assigned group. D. At 24 months, the percentage of participants in the control group with a weight that was lower than their weight at baseline was 52. Kansas primary care weighs in: a pilot randomized trial of a chronic care model program for obesity in 3 rural Kansas primary care practices. Comparison of methods for delivering a lifestyle modification program for obese patients: a randomized trial. The other intervention offered these remote sources of support but reflected common practice in efficacy trials by also providing face-to-face group and individual sessions conducted by health coaches. Coaches were trained before enrollment of the first participant and on a quarterly basis thereafter. 2016. Appel,. No other potential conflict of interest relevant to this article was reported. 4% in the group receiving in-person support, and 38. (2016) The impact of continued intervention on weight: Five-year results from the weight loss maintenance trial. (2016) Long-Term Effects of an Internet-Mediated Pedometer-Based Walking Program for Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial. Internal Medicine Date of Proposal: February 5, 2009 I. Transtheoretical model-chronic disease care for obesity in primary care: a randomized trial. CrossRef 25 Shoaib Mohammad, Jamal Ahmad. A randomized trial comparing human e-mail counseling, computer-automated tailored counseling, and no counseling in an Internet weight loss program. Outcomes were compared between each intervention group and the control group and between the two intervention groups. Inge. 5%) at 12 months, and for 392 (94. , reduce calorie intake and increase exercise) and to motivate their patients. 10,11 For this trial, Healthways, a disease-management company, also provided support. Diabetes and Non-Alcoholic Fatty Liver Disease. Study Groups Randomization was stratified according to sex and was generated in blocks of 3 and 6 with the use of a Web-based program. Fourth, although we collected data on cardiovascular risk factors (in the Supplementary Appendix ), we did not design the trial to reconfirm the well-established relationship between weight reduction and improvements in blood pressure, lipid profile, and glucose levels. , Thomas A. Weight-loss coaches encouraged participants to complete the learning modules and provided positive reinforcement of key behaviors, with an emphasis on self-monitoring of weight, calorie intake, and exercise. Minges, Caroline R. The same modeling approach was used for the dependent variables of percentage change in weight and change in BMI. 24,25 Second, the study was a single-center trial, although it did involve six clinics. 5 in the first 6 months and 1 in the next 18 months, and the median number of individual sessions attended was 4 in the first 6 months and 1 in the last 18 months. 2% in the group receiving remote support only. Discussion In this comparative effectiveness trial, in which obese medical patients with at least one cardiovascular risk factor were enrolled, two behavioral interventions — one involving no in-person contact with weight-loss coaches associated with the study or with other participants — achieved clinically relevant weight loss. perception of Hong Kong Shoppers regarding the service and product satisfaction. The report can also serve as a basic industry. (2016) Evaluation of a culturally-adapted lifestyle intervention to treat elevated cardiometabolic risk of Latino adults in primary care (Vida Sana): A randomized controlled trial. e. Participants in the control group received brief advice but none of the above resources. In addition, percentages of participants in each of the three study groups who met various weight-loss thresholds were compared with the use of a binomial model. Please note that instructions (in italics) should be deleted and replaced by the appropriate. (2016) Results of a course based obesity intervention program during work. The other intervention provided in-person support during group and individual sessions, along with the three remote means of support. Compare the effectiveness of the stage specific smoking cessation counseling intervention with the control intervention by evaluating the impact. The results of these trials were inconsistent, and most of them had one or more limitations (e. We excluded patients who had recently lost 5% or more of their body weight or were taking medications that cause weight gain or prevent weight loss (e. , and Frederick L. Include a description of the background to your topic. Effects of comprehensive lifestyle modification on diet, weight, physical fitness, and blood pressure control: 18-month results of a randomized trial. For the remainder of the study, participants in the group receiving in-person support were offered two monthly contacts (one group session and one individual session, with the latter conducted either in person or by telephone), and the group receiving only remote support continued to be offered monthly calls. CrossRef 42 Marilyn L Moy, Carlos H Martinez, Reema Kadri, Pia Roman, Robert G Holleman, Hyungjin Myra Kim, Huong Q Nguyen, Miriam D Cohen, David E Goodrich, Nicholas D Giardino, Caroline R Richardson. Third, the relative contribution of each component of the interventions (personalized counseling, reinforcement by PCPs, and Web-based support) is difficult to assess. This approach produces valid estimates if data are missing at random. Jackson, Gary A. This research report can serve as a guide for any new entrant who wants to enter in this fruit juice market in India. Schwartz, Veronica Perez-Rosas, Rada Mihalcea, Linda Snetselaar. , pregnancy, bariatric surgery, or amputation) were included in the analysis, which was conducted with the use of a saturated-means, repeated-measures, mixed-effects model for visit-specific weight, with indicators for missing data. An unstructured covariance structure was used to relate the repeated measures. Finally, the paradigm of remote counseling, reinforcement of patient change by PCPs, and use of a Web site with portals for patients, counselors, and physicians could improve the management of other chronic conditions. Moreover, the descriptive research method will be utilized. The first author wrote the article and vouches for the accuracy of the data and the analyses. In the United States, approximately one third of adults are obese. Diu, J. McColl, V. S. These approaches were modeled on those tested in previous trials. Hecht, Jennifer Daubenmier. Methods Oversight This trial is one of three independent trials in the Practice-based Opportunities for Weight Reduction (POWER) trials, each supported by a grant from the National Heart, Lung, and Blood Institute. Still, to our knowledge, it is one of the longest trials of a remote (telephone- or Web-based) intervention. (2016) The POWeR of looking into the black box. org. Our results have implications for the delivery of behavioral interventions. Groessl, Samuel B. (2016) A pilot study of health and wellness coaching for fibromyalgia. Independent but coordinated trials: insights from the Practice-based Opportunities for Weight Reduction Trials Collaborative Research Group. Adamson, E. Methods We conducted a randomized, controlled trial to examine the effects of two behavioral weight-loss interventions in 415 obese patients with at least one cardiovascular risk factor. ) Participants in both intervention groups were encouraged to log on to the study-specific Web site weekly. 21-23 Our trial has limitations. The Diabetes Prevention Program (DPP): description of lifestyle intervention. shows the key features of the two intervention groups. Pfeiffer, Teodora Handjieva-Darlenska, Petr Hlavaty, Steen Stender, Thomas M. , glucocorticoids or second-generation antipsychotic medications). CrossRef 47 Cathrien RL Beishuizen, Blossom CM Stephan, Willem A van Gool, Carol Brayne, Ron JG Peters, Sandrine Andrieu, Miia Kivipelto, Hilkka Soininen, Wim B Busschers, Eric P Moll van Charante, Edo Richard. Long-term weight loss and changes in blood pressure: results of the Trials of Hypertension Prevention, phase II. Sherin. Svetkey, Lawrence J. Fazzino, Danielle Christifano, Leslie Eiland, Andjela Drincic. (2016) Protocol for the Rural Engagement in Primary Care for Optimizing Weight Reduction (RE-POWER) Trial: Comparing three obesity treatment models in rural primary care. Kaplan. shows the actual and recommended rates of study participation in the intervention groups. (2016) Retrofit Weight-Loss Outcomes at 6, 12, and 24 Months and Characteristics of 12-Month High Performers: A Retrospective Analysis. (2016) Behavioral Treatment of the Patient with Obesity. Hassan, V. CrossRef 27 Ken Resnicow, Donna Harris, Richard Wasserman, Robert P. Consequently, even though it is recommended that clinicians offer intensive counseling and behavioral support to their obese patients, 9 practicing physicians lack effective, empirically supported models of treatment to guide their efforts in helping obese patients lose weight. Farrell. There was also a control group in which weight loss was self-directed. Participation Rates Table 4 Table 4 Numbers of Recommended and Actual Contacts According to Intervention Group. (2016) The Electronic CardioMetabolic Program (eCMP) for Patients With Cardiometabolic Risk: A Randomized Controlled Trial. Participation in group sessions, although strongly encouraged, was initially low and declined further over the course of the study. Participants were asked to make in-person follow-up visits 6, 12, and 24 months after randomization. Thus, this study will determine the complaint behavior of Hong Kong shoppers. A. 3% as compared with 74. Each participant who was assigned to an active intervention received automated monthly e-mail messages summarizing his or her progress. (2016) New directions for diabetes prevention and management in behavioral medicine. (2016) Reduced reward-driven eating accounts for the impact of a mindfulness-based diet and exercise intervention on weight loss: Data from the SHINE randomized controlled trial. (2016) Cardiovascular effects of bariatric surgery. 7% at 6 months and 15. For example, we did not have a run-in period or conduct an adherence test before randomization, required only two visits by potential participants to determine eligibility, and modified our interventions considerably, mostly by reducing the intensity of the intervention and increasing flexibility. Kelly, Thomas H. They also received brochures and a list of recommended Web sites promoting weight loss. Reynolds, M. Wadden. Stevens.
Byrne, E. Ford. Changes in plasma lipids and lipoproteins in overweight men during weight loss through dieting as compared with exercise. Rubin, Ph. The study includes both primary and secondary. Both intervention groups used the Web site frequently. Louis, Ph. There were no deaths or serious hypoglycemic events. (2016) Metabolic Syndrome: An Evolving Clinical Construct. (2016) Reducing depression during the menopausal transition with health coaching: Results from the healthy menopausal transition randomised controlled trial. , small sample size, brief duration, low rate of follow-up, or a combination thereof). D. Effects of weight loss and sodium reduction intervention on blood pressure and hypertension incidence in overweight people with high-normal blood pressure: the Trials of Hypertension Prevention, phase II. 2%) at 6 months, for 355 (85. Other weight-related outcomes were percentage of weight change from baseline, percentage of participants without weight gain, percentage of participants who lost at least 5% of their initial weight, and change from baseline in body-mass index (BMI, the weight in kilograms divided by the square of the height in meters). Jacob, M. Statistical Analysis The primary outcome was change in weight from baseline to 24 months. Excess deaths associated with underweight, overweight, and obesity. Long-term effects of a lifestyle intervention on weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: four-year results of the Look AHEAD trial. Williams. Explain why you have chosen the topic - give both. 0% at 6 months and 13. Few trials have attempted behavioral weight-loss strategies in the primary care setting, and none have implemented interventions similar to those tested in the POWER trial. At data-collection visits, 48 hospitalizations were reported (15 in the control group, 15 in the group receiving remote support, and 18 in the group receiving in-person support). The extent of weight loss was similar to that achieved in many efficacy studies. The coaches for the group receiving in-person support were employees of Johns Hopkins University, and the coaches for the group receiving only remote support were employees of Healthways. PREMIER -- a trial of lifestyle interventions for blood pressure control: intervention design and rationale. M. The model included adjustment for clinic, sex, age, and race or ethnic group. Study Population The study population consisted of obese adults who were at least 21 years of age and had one or more cardiovascular risk factors (hypertension, hypercholesterolemia, or diabetes). g. 1 Obesity adversely affects each of the major cardiovascular risk factors — blood pressure, lipid profile, and diabetes. Weight Loss After randomization, weight was recorded for 366 participants (88. (For more information on the interventions, see the protocol and the Supplementary Appendix, available at NEJM. Dr. D. Wing. Give a clear and succinct title, indicating the problem area around which the research will be undertaken. org). Tony Buffington. Effects of comprehensive lifestyle modification on blood pressure control: main results of the PREMIER clinical trial. CrossRef 35 Stefan Sammito. (2016) Fast versus slow weight loss: development process and rationale behind the dietary interventions for the TEMPO Diet Trial. e. Tackling obesity: is primary care up to the challenge. Seimon, J. Jebb, Paul Aveyard,. (2016) Systematic review and meta-analysis of internet-delivered interventions providing personalized feedback for weight loss in overweight and obese adults. 4% in the group receiving in-person support and 77. 12-14 In contrast with the findings in most weight-loss trials, 19,20 however, participants sustained weight loss to the end of the trial. Johns Hopkins University has an institutional consulting agreement with Healthways. (2016) The Impact of Gender and Protein Intake on the Success of Weight Maintenance and Associated Cardiovascular Risk Benefits, Independent of the Mode of Food Provision: The DiOGenes Randomized Trial. PCPs used this report to provide patients with basic guidance (i. The word guides are a maximum. Participants had an equal chance of being assigned to any one of the three study groups. Automated re-engagement e-mail messages were sent to participants who had not logged on to the Web site in the preceding 7 days. Prevalence and trends in obesity among US adults, 1999-2008. Media in This Article Figure 1 Mean Weight Change According to Randomized Group. The percentage of participants who dropped out of the intervention (defined as having no contact with a coach and no use of study Web site for 2 months) was 5. Tsai and Wadden conducted a systematic review of the literature on this topic. Trained research staff who were not informed of the group assignment performed the measurements. , Nowella Durkin, Richard R. V. CrossRef 41 Stefanie Painter, Gary Ditsch, Rezwan Ahmed, Nicholas Buck Hanson, Kevin Kachin, Jan Berger. Screening for obesity in adults: recommendations and rationale. Wolever, Meg Jordan, Karen Lawson, Margaret Moore. Gibson, R. Data Collection Eligibility, baseline, and follow-up data were collected by telephone, through the Web, and through in-person visits. Alfredo Martinez. A. H. (2016) Web-Based Interventions Targeting Cardiovascular Risk Factors in Middle-Aged and Older People: A Systematic Review and Meta-Analysis. Healthways employees contributed to the study design, particularly on technical matters related to the design of the study-specific Web site. Bell, A. (2016) Management of obesity in patients with type 2 diabetes mellitus in primary care. To be eligible for the trial, potential participants had to be a patient at one of the participating primary care practices, have regular access to a computer, and have basic computer skills (i. 1% in the group receiving remote support only. Influence of weight reduction on blood pressure: a meta-analysis of randomized controlled trials. Dubin, Jaya Vadivelu, Nedret Copur-Dahi, Leslie Miranda, Dana Palermo, Braj Pandey, Erik J. , could enter data into a Web site and send and receive e-mail). Harms, Noura Bashshur, Charles R. We hypothesized that patients assigned to both active interventions would achieve greater weight loss than those in the control group. Recent advances in Internet-delivered, evidence-based weight control programs for adults. Richardson. Supported by grants from the National Heart, Lung, and Blood Institute (HL087085), the Prevention and Control Core of the Baltimore Diabetes Research and Training Center (P60DK079637), and the National Center for Research Resources (UL1RR025005) and by Healthways. Bachmann, S. Few weight-loss trials have examined the effect of behavioral interventions in clinical practice, 8 and the results of these trials have been inconsistent. (2016) A Simple Dietary Questionnaire Correlates With Formal Dietitian Evaluation and Frequently Identifies Specific Clinical Interventions in an Outpatient Gastroenterology Clinic. Role of the PCP PCPs played a supportive role in the study. For this study, primary research and secondary research will be used. Specific Aims In conducting this study, we will accomplish the following specific aims: Specific Aim 1. Body-mass index and cause-specific mortality in 900 000 adults: collaborative analyses of 57 prospective studies. Rhodes, Kevin M. Caterson, A. Primary research involves collecting information from both consumers and retailers so as to get better understanding about the market. Its duration, although longer than that of many weight-loss trials, was only 2 years. Eight clinics were invited to participate in the study, and six accepted. All weights obtained before a protocol-defined censoring event (i. Participants in the control group met with a weight-loss coach at the time of randomization and, if desired, after the final data-collection visit, at 24 months. 6,12-14 There was no run-in period, no test given before randomization to determine adherence to study procedures, and no requirement that participants attend group sessions. The research staff who notified participants of their assignment were not involved in the collection of follow-up data. Markovic, N. Treatment of obesity in primary care practice: the Practice Based Opportunities for Weight Reduction (POWER) Trial at Johns Hopkins. CrossRef 2 Shivakumar Chitturi, Geoffrey C. CrossRef 44 Kristen MJ Azar, Suneil Koliwad, Tak Poon, Lan Xiao, Nan Lv, Robert Griggs, Jun Ma. Kaye, Sarah Simunovich, Frank G. 8 Of the 10 trials identified, 4 trials tested the use of PCP counseling alone, 3 tested PCP counseling with pharmacotherapy, and 3 tested a collaborative approach in which the intervention was delivered by care providers other than PCPs. P. Unlike efficacy trials, in which one eligibility criterion is confirmed availability for group sessions, we imposed no such requirement, a policy that no doubt contributed to low attendance at group sessions. Sainsbury. O. We further hypothesized that patients in the group receiving in-person support would achieve greater weight loss than those in the group receiving only remote support. Louis reports receiving consulting fees from Bristol-Myers Squibb and Merck and royalties from Taylor and Francis Publishing. The study was conducted according to the protocol (available with the full text of this article at NEJM. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. In the group receiving in-person support, most contact with coaches during the first 6 months occurred in face-to-face group sessions. Abstract Background Obesity and its cardiovascular complications are extremely common medical problems, but evidence on how to accomplish weight loss in clinical practice is sparse. At routinely scheduled visits, each PCP received and reviewed a progress report on any of their patients who had been assigned to an intervention group (see the sample report in the Supplementary Appendix ). (2016) Advances in Motivational Interviewing for Pediatric Obesity. Adverse Events There was one serious adverse event that may have been related to the study. (2016) Advancing a new evidence-based professional in health care: job task analysis for health and wellness coaches. Typically, primary care providers (PCPs) were not directly involved in the intervention. Doarn. research. (2016) Impact of newer self-monitoring technology and brief phone-based intervention on weight loss: A randomized pilot study. Funk, Njeri Karanja, Ning Smith, Victor J. J Newham, R. Driver, Neil J. Title of Proposed Research Project Medical Students as Mediators of Change in Tobacco Use. (2016) Practice Policy Statement. (2016) The effects of health coaching when added to a wellness program. Sforzo, C. In this method, it is possible that the study would be cheap and quick. Stone. (2016) The Empirical Foundations of Telemedicine Interventions in Primary Care. In the group receiving in-person support only, the median number of phone calls was 4 in the first 6 months and 11 in the last 18 months. The median number of group sessions attended was 6. Kaye Kramer, Veronica Luna, Jun Ma. During the next 3 months, participants receiving in-person support were offered three monthly contacts (one group session and two individual sessions), whereas the group receiving only remote support were offered 1 call each month. If patients were not actively participating in their assigned intervention, the coaches sent re-engagement letters on behalf of the PCP. 9% at 24 months for the group receiving in-person support. Araujo-Soares. The final decisions regarding the content and composition of the manuscript and the decision to submit it for publication were made by the academic investigators. 0% at 24 months for the group receiving remote support and 8. CrossRef 20 Naji Alamuddin, Thomas A. Treatment of obesity in primary care practice in the United States: a systematic review. Franklin, T. To address the need for treatment models, we conducted a randomized, controlled trial to determine the effectiveness of two behavioral weight-loss interventions — including one without in-person contact — in obese patients with at least one cardiovascular risk factor. CrossRef 29 A. (2016) Prepare, a randomized trial to promote and evaluate weight loss among overweight and obese women planning pregnancy: Study design and rationale. The study intends to investigate the. CrossRef 40 Santiago Navas-Carretero, Claus Holst, Wim H. Journal of the American College of Nutrition 35:1, 20-30. Long ago, fitness clubs used to be a place where people make visit solely for the purpose of health improvement and nothing more. The Prevention and Control Core of the Baltimore Diabetes Research and Training Center contributed to the data analysis. At each of these visits, weight was measured on a high-quality, calibrated digital scale, with the participant wearing light, indoor clothes and no shoes. The theoretical framework for the two active interventions was based on social cognitive theory and incorporated behavioral self-management approaches designed to help participants set weight-related goals, self-monitor weight and weight-related behaviors (exercise and reduced calorie intake), increase self-efficacy and social support, and solve problems. (2016) Effect Sizes and Primary Outcomes in Large-Budget, Cardiovascular-Related Behavioral Randomized Controlled Trials Funded by NIH Since 1980. Almeida, Kylie Marsh, Karen Murray, Martha Hickey, Moira Sim, Andrew Ford, Leon Flicker. (2016) Lifestyle interventions for weight loss in adults with severe obesity: a systematic review. The primary analysis was based on the intention-to-treat principle. The number of reports reviewed by the PCPs was similar in the two groups. One participant in the group receiving in-person support was assaulted while exercising and had musculoskeletal injuries.
