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      Clinic Versus Online Social Network–Delivered Lifestyle Interventions: Protocol for the Get Social Noninferiority Randomized Controlled Trial

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          Abstract

          Background

          Online social networks may be a promising modality to deliver lifestyle interventions by reducing cost and burden. Although online social networks have been integrated as one component of multimodality lifestyle interventions, no randomized trials to date have compared a lifestyle intervention delivered entirely via online social network with a traditional clinic-delivered intervention.

          Objective

          This paper describes the design and methods of a noninferiority randomized controlled trial, testing (1) whether a lifestyle intervention delivered entirely through an online social network would produce weight loss that would not be appreciably worse than that induced by a traditional clinic-based lifestyle intervention among overweight and obese adults and (2) whether the former would do so at a lower cost.

          Methods

          Adults with body mass index (BMI) between 27 and 45 kg/m 2 (N=328) will be recruited from the communities in central Massachusetts. These overweight or obese adults will be randomized to two conditions: a lifestyle intervention delivered entirely via the online social network Twitter (Get Social condition) and an in-person group-based lifestyle intervention (Traditional condition) among overweight and obese adults. Measures will be obtained at baseline, 6 months, and 12 months after randomization. The primary noninferiority outcome is percentage weight loss at 12 months. Secondary noninferiority outcomes include dietary intake and moderate intensity physical activity at 12 months. Our secondary aim is to compare the conditions on cost. Exploratory outcomes include treatment retention, acceptability, and burden. Finally, we will explore predictors of weight loss in the online social network condition.

          Results

          The final wave of data collection is expected to conclude in June 2019. Data analysis will take place in the months following and is expected to be complete in September 2019.

          Conclusions

          Findings will extend the literature by revealing whether delivering a lifestyle intervention via an online social network is an effective alternative to the traditional modality of clinic visits, given the former might be more scalable and feasible to implement in settings that cannot support clinic-based models.

          Trial Registration

          ClinicalTrials.gov NCT02646618; https://clinicaltrials.gov/ct2/show/NCT02646618 (Archived by WebCite at http://www.webcitation.org/6v20waTFW)

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          Most cited references39

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          The Automated Self-Administered 24-hour dietary recall (ASA24): a resource for researchers, clinicians, and educators from the National Cancer Institute.

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            The Finnish Diabetes Prevention Study (DPS): Lifestyle intervention and 3-year results on diet and physical activity.

            To describe the 1) lifestyle intervention used in the Finnish Diabetes Prevention Study, 2) short- and long-term changes in diet and exercise behavior, and 3) effect of the intervention on glucose and lipid metabolism. There were 522 middle-aged, overweight subjects with impaired glucose tolerance who were randomized to either a usual care control group or an intensive lifestyle intervention group. The control group received general dietary and exercise advice at baseline and had an annual physician's examination. The subjects in the intervention group received additional individualized dietary counseling from a nutritionist. They were also offered circuit-type resistance training sessions and advised to increase overall physical activity. The intervention was the most intensive during the first year, followed by a maintenance period. The intervention goals were to reduce body weight, reduce dietary and saturated fat, and increase physical activity and dietary fiber. The intervention group showed significantly greater improvement in each intervention goal. After 1 and 3 years, weight reductions were 4.5 and 3.5 kg in the intervention group and 1.0 and 0.9 kg in the control group, respectively. Measures of glycemia and lipemia improved more in the intervention group. The intensive lifestyle intervention produced long-term beneficial changes in diet, physical activity, and clinical and biochemical parameters and reduced diabetes risk. This type of intervention is a feasible option to prevent type 2 diabetes and should be implemented in the primary health care system.
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              Using Facebook and text messaging to deliver a weight loss program to college students.

              Between 31 and 35% of the college-aged population is overweight or obese, yet few weight loss trials for this population have been conducted. This study examined the feasibility, acceptability, and initial efficacy of a technology-based 8-week weight loss intervention among college students. Students (N = 52) were randomly assigned to one of the three arms: Facebook (n = 17); Facebook Plus text messaging and personalized feedback (n = 18); Waiting List control (n = 17), with assessments at 4 weeks and 8 weeks (post-treatment). Participants were 20.47 ± 2.19 years old, 86.45 ± 17.11 kg, with a body mass index of 31.36 ± 5.3 kg/m(2) . Participants were primarily female (86.5%), and the sample was racially diverse (57.7% Caucasian, 30.8% African American, 5.8% Hispanic, and 5.7% other races). The primary outcome was weight loss after 8 weeks (post-treatment); 96.0% of the participants completed this assessment. At 8 weeks, the Facebook Plus group had significantly greater weight loss (-2.4 ± 2.5 kg) than the Facebook (-0.63 ± 2.4 kg) and Waiting List (-0.24 ± 2.6 kg) (both Ps < 0.05). Weight change at 8 weeks was not significantly different between the Facebook and Waiting List groups. Results show preliminary efficacy and acceptability of the two active intervention arms (97.0% found the program helpful, 81.3% found the videos/handouts helpful, and 100% would recommend the program to others). Results indicate the potential for an innovative weight loss intervention that uses technology platforms (Facebook and text messaging) that are frequently used and already integrated into the cultural life of college students. Copyright © 2012 The Obesity Society.
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                Author and article information

                Contributors
                Journal
                JMIR Res Protoc
                JMIR Res Protoc
                ResProt
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                1929-0748
                December 2017
                11 December 2017
                : 6
                : 12
                : e243
                Affiliations
                [1] 1 Department of Community Health Sciences Boston University School of Public Health Boston, MA United States
                [2] 2 Department of Allied Health Sciences College of Agriculture, Health, and Natural Resources University of Connecticut Storrs, CT United States
                [3] 3 Division of Preventive and Behavioral Medicine Department of Medicine University of Massachusetts Medical School Worcester, MA United States
                Author notes
                Corresponding Author: Sherry L Pagoto sherry.pagoto@ 123456uconn.edu
                Author information
                http://orcid.org/0000-0002-7019-5072
                http://orcid.org/0000-0002-9884-9824
                http://orcid.org/0000-0001-6381-7323
                http://orcid.org/0000-0001-8270-2302
                http://orcid.org/0000-0003-4867-4728
                http://orcid.org/0000-0001-5545-8690
                http://orcid.org/0000-0003-3321-6070
                http://orcid.org/0000-0003-2317-3716
                http://orcid.org/0000-0002-2462-8797
                Article
                v6i12e243
                10.2196/resprot.8068
                5742659
                29229591
                3dc5f211-d591-445e-a731-a4a3c3f71c12
                ©Monica L Wang, Molly E Waring, Danielle E Jake-Schoffman, Jessica L Oleski, Zachary Michaels, Jared M Goetz, Stephenie C Lemon, Yunsheng Ma, Sherry L Pagoto. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 11.12.2017.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                : 20 July 2017
                : 30 August 2017
                : 22 September 2017
                : 23 September 2017
                Categories
                Protocol
                Protocol

                methods,randomized controlled trial,life style,obesity,weight loss,social support

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