Recruitment

Recruitment Status
Enrolling by invitation
Estimated Enrollment
Same as current

Summary

Conditions
  • Cardiovascular Risk Factor
  • Diet, Healthy
  • Weight Loss
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Study participants will be randomized to either the intervention group (Med-Diet Weight Loss Program) or an enhanced usual care control group (WW); both groups will participate in the respective programs for two years.Masking: Single (Outcomes Assessor)Masking Description: The investigators (excluding bio-statistician) will be masked to weight change and other major outcomes (will not have access to the data) until all data are collected. The bio-statistician will have access to study group assignment as liaison to the Data Safety Monitoring CommitteePrimary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

Description

Below, each of the treatment arms is described in detail. Med-South Weight Loss Program Most weight loss programs offer weekly one-on-one or group counseling sessions for 16-20 weeks. The Med-South Weight Loss Program is different and is given in 3 phases. The program begins with Phase I, a 4-month ...

Below, each of the treatment arms is described in detail. Med-South Weight Loss Program Most weight loss programs offer weekly one-on-one or group counseling sessions for 16-20 weeks. The Med-South Weight Loss Program is different and is given in 3 phases. The program begins with Phase I, a 4-month lifestyle phase that focuses on the "basics" of healthy eating rather than weight loss. Over the next 8 months in Phase II, we focus on weight loss, followed by a year-long (Phase III) phase to help maintain weight loss. In Phase I, the main counseling sessions happen at monthly visits, to which check-in phone calls are added. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks, depending on participants' progress. There are also check in phone calls-the number will vary based on progress. During Phase III, there are 2 main visits and follow-up phone calls. More details about these visits are in the table below. Some of the counseling visits will be face-to-face with the counselor and some by phone. Only one member of a family may join this study, but other family members are invited to take part in face-to-face and phone counseling sessions. (As of June 2020, due to COVID-19 only one other family member or friend may come with you to in-person visits.) Of the 14 core counseling sessions), the face-to-face format will be required for only 5 (the 1st session of each Phase, after 2 months of the weight loss program, and approximately 1/2 through the year long maintenance phase). (As of June 2020, due to COVID-19, only these visits will be in person. All the others will be by phone or videoconferencing, until further notice based on updated COVID-19 guidelines.) During face-to-face sessions, the participant and the counselor will sit side-by-side and use a web-based program or the paper format to review educational materials, select dietary goals, and list first steps to reach these goals. (As of June 2020, due to COVID-19, counselor and participant will sit more than 6 feet apart and a large wall mounted monitor will be used to review study materials. This protocol will be followed until further notice based on updated COVID-19 guidelines.) If the phone format is used for major counseling sessions, the participant may view the educational content online or use the paper version. The program also includes brief telephone calls to check on progress towards goals selected at previous sessions and provide support for lifestyle change. The number of phone calls will depend on the participant meeting his/her personal weight loss goals in Phase II or keeping the weight off in Phase III. Detail for each Phase is given below. Phase I 8 total contacts 4 core sessions: the first must be in-person; choice of in-person or phone for all others 4 follow-up phone calls Core session = 45-60 min. Follow-up call = 15 min. total time: 4 - 5 hours Phase II 14 core sessions: the first and third must be in-person; choice of in-person or phone for all others. 6-12 follow-up phone calls Core session (In-person) = 45-60 min. Core session (phone) = 30-45 min. Follow-up call = 20-30 min. Total time 8.7 - 14 hours (core) 4.7 - 9.5 hours (Follow-up) Phase III 2 core sessions (both in-person) 12-24 follow-up phone calls (1-2 per month) Core session (In-person) = 45-60 min. Follow-up call = 15-20 min. Total time 1.25 - 2 hours (Core) 3 - 8 hours (Follow-up) 2-Year Program TOTAL 44 - 60 Contacts -- 21.7 - 38.5 hours WW™ Weight Loss Program Those randomized to WW™ will have access to both the Workshop and Digital components of the WW™ program for 2 years. WW offers in-person coaching and community-based learning through weekly Workshops at WW Studios.The Workshop component allows for attending weekly group meeting at a WW™ studio (local WW™ office). (As of June 2020, due to COVID-19, the workshop component will be available in a virtual videoconferencing [Zoom™] format until further notice based on updated COVID-19 guidelines.) The Digital component can be accessed using the WW™ website or the smart phone App. The digital tools available thought the WW Digital program include food tracking (either manually or with bar code scanning), progress charts, lifestyle coaching with 24/7 chat with a WW Coach, ability to track activity (manually or by syncing a fitness tracking device), incentives for behavior change (WellnessWins), recipes, and even local restaurant recommendations using GPS. Those in the WW group will also have access to Connect, WW's members-only digital community. The WW™ program uses "SmartPoints" assigned to foods based on energy content and nutritional value, allocating a certain number of points to users daily based on their starting weight, weight loss goals, age and sex. Participants will receive a personalized SmartPoints budget made up of Daily SmartPoints, plus some extra Weekly SmartPoints for those days when a cushion is needed.

Tracking Information

NCT #
NCT04302727
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Carmen D Samuel-Hodge, PhD University of North Carolina, Chapel Hill Principal Investigator: Thomas C Keyserling, MD University of North Carolina, Chapel Hill