Randomized Explanatory Trial of a Mediterranean Dietary Pattern Weight Loss Intervention for Primary Care Practices
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Weight Loss
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 360
- Locations
- 1
- Primary Endpoint
- Percent Weight Change From Baseline to Month 24
- Status
- Completed
- Last Updated
- 6 months ago
Overview
Brief Summary
This study will compare a new weight loss program that focuses on a healthy eating pattern, with WW™ (formally Weight Watchers), an effective and widely available weight loss program. Study researchers have developed an adapted version of the Mediterranean eating pattern to be more acceptable and realistic for southerners; this adapted version is known as "Med-South." Those who take part in the study will be randomly assigned to either the Med-South weight loss program or WW™. Both programs will last for 2 years with measurement visits at the start of the study and at 4-, 12- and 24-month follow-up. While the primary outcome measured by the trial will be weight loss at 24 months, researchers will collect other data which may show additional health benefits of the Med-South diet. The study team will measure blood markers of inflammation, which are known to improve with better diet quality. Researchers will also measure participants' skin carotenoid levels, which increase with greater fruit and vegetable consumption. The study will be conducted within 2 regional catchment areas (n=360 participants) representing a diverse spectrum of patients and settings. Patients with a BMI ≥ 30 kg/m^2 will be enrolled and randomized to intervention or augmented usual care. To assure adequate subgroup representation, ≥ 40% of the sample will have diabetes, ≥ 40% will be male, and ≥ 40% will be African American. The intervention will be delivered in 3 phases over 24 months by research staff: Phase I (4 months) focuses on adopting a Med-style dietary pattern; Phase II (8 months) on weight loss; and Phase III (12 months) on weight loss maintenance. Outcomes will be assessed at 4, 12, and 24 months. The primary outcome is weight loss at 24 months. Secondary outcomes include change in physiologic, behavioral, and psychosocial measures. Researchers will also assess implementation cost and the incremental cost-effectiveness of the intervention relative to the augmented usual care group.
Detailed 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 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female
- •English speaking
- •Ages 18-75 (inclusive)
- •BMI \> or = 30 kg/m\^2
- •Approval for participation by primary care clinician
- •Established patient at participating practice defined as at least one prior visit at the practice within the prior 2 years
- •Access to telephone
- •No plans to move from the area for at least 1 year
- •Free living to the extent that participant has control over dietary intake
- •Those with known cardiovascular disease will be allowed to participant
Exclusion Criteria
- •Participant in intensive weight loss program (more than 6 visits) in the prior year
- •Another family member or household member is a study participant. Only one member of each household may take part in this study.
- •Considering bariatric surgery in the next year or prior bariatric surgery
- •Type 1 diabetes. Rationale is patients with type 1 diabetes already received intensive dietary counseling with a focus on total and distribution of daily carbohydrates.
- •Pregnancy/breastfeeding or intended pregnancy in the next year
- •History of malignancy, other than non-melanoma skin cancer, unless surgically or medically cured \> 5 years ago or in remission. Patients with localized prostate and breast cancer diagnosed during the course of routine screening will not be excluded.
- •Advanced kidney disease (estimated creatinine clearance \< 30 mL/min)
- •Known drug or alcohol misuse in the past 2 years
- •Known psychosis or major psychiatric illness. Those with major depression who have responded to treatment may participate.
Outcomes
Primary Outcomes
Percent Weight Change From Baseline to Month 24
Time Frame: Baseline, Month 24
Weight will be collected by study staff who are masked to treatment using scales tested monthly for accuracy up to 350 pounds.
Secondary Outcomes
- Percent Weight Change From Baseline to Months 4 and 12(Baseline, Months 4 and 12)
- Percentage Weight From Baseline Through Follow-Up by Sub-Groups(Baseline, Months 4, 12, and 24)
- Mean Weight Change From Baseline Through Follow-Up(Baseline, Months 4, 12, and 24)
- Mean Change in Systolic Blood Pressure From Baseline Through Follow-Up(Baseline, Months 4, 12, and 24)
- Mean Change in Diastolic Blood Pressure From Baseline Through Follow-Up(Baseline, Months 4, 12, and 24)
- Mean Change in Total Cholesterol From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change in HDL-Cholesterol From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change in Triglycerides From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change LDL-cholesterol From Baseline Through Follow-up(Baseline, Month 4, 12, and 24)
- Mean Change in A1c From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change in CRP (C-Reactive Protein) From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change in Interleukin (IL) IL-6 From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change in Tumor Necrosis Factor (TNF) TNF-alpha From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change in Skin Carotenoids From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change in Quality of Life Scale From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change in Alternate Healthy Eating Index (AHEI)-2010 From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change in Global Physical Activity Questionnaire (GPAQ) From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change in Weight Loss Self-Efficacy From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change in Dietary Self-Regulation From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change in Eating Attitudes From Baseline Through Follow-Up (Cognitive Restraint)(Baseline, Month 4, 12, and 24)
- Mean Change in Eating Attitudes From Baseline Through Follow-Up (Uncontrolled Eating)(Baseline, Month 4, 12, and 24)
- Mean Change in Eating Attitudes From Baseline Through Follow-Up (Emotional Eating)(Baseline, Month 4, 12, and 24)
- Mean Change in Diet Self-Efficacy From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change in Self-Weighing Behaviors From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Economic Outcome--Incremental Cost-Effectiveness(Month 24)
- Economic Outcome--Incremental Cost Per Quality Adjusted Life Year (QALY) Gained(Month 24)