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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
360
Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
UNC Center for Health Promotion and Disease Prevention
Chapel Hill, North Carolina, United States
Percent Weight Change From Baseline to Month 24
Weight will be collected by study staff who are masked to treatment using scales tested monthly for accuracy up to 350 pounds.
Time frame: Baseline, Month 24
Percent Weight Change From Baseline to Months 4 and 12
Weight will be collected by study staff who are masked to treatment using scales tested monthly for accuracy up to 350 pounds.
Time frame: Baseline, Months 4 and 12
Percentage Weight From Baseline Through Follow-Up by Sub-Groups
Weight will be collected by study staff who are masked to treatment using scales tested monthly for accuracy up to 350 pounds. Assess difference between study groups in percentage losing ≥ 5% body weight for all participants and across 3 pre-specified subgroups: 1) participants with vs. without diabetes; 2) females vs. males; and 3) Whites vs. African Americans.
Time frame: Baseline, Months 4, 12, and 24
Mean Weight Change From Baseline Through Follow-Up
Weight will be collected by study staff who are masked to treatment.
Time frame: Baseline, Months 4, 12, and 24
Mean Change in Systolic Blood Pressure From Baseline Through Follow-Up
Blood pressure assessed by Omron-907xl, average of 3 readings.
Time frame: Baseline, Months 4, 12, and 24
Mean Change in Diastolic Blood Pressure From Baseline Through Follow-Up
Blood pressure assessed by Omron-907xl, average of 3 readings.
Time frame: Baseline, Months 4, 12, and 24
Mean Change in Total Cholesterol From Baseline Through Follow-Up
Total cholesterol assessed by commercial lab (LabCorp).
Time frame: Baseline, Month 4, 12, and 24
Mean Change in HDL-Cholesterol From Baseline Through Follow-Up
HDL-Cholesterol assessed by commercial lab (LabCorp).
Time frame: Baseline, Month 4, 12, and 24
Mean Change in Triglycerides From Baseline Through Follow-Up
Triglycerides as assessed by commercial lab (LabCorp).
Time frame: Baseline, Month 4, 12, and 24
Mean Change LDL-cholesterol From Baseline Through Follow-up
Calculated from above lipid assessments by commercial lab (LabCorp).
Time frame: Baseline, Month 4, 12, and 24
Mean Change in A1c From Baseline Through Follow-Up
A1c assessed by commercial lab (LabCorp).
Time frame: Baseline, Month 4, 12, and 24
Mean Change in CRP (C-Reactive Protein) From Baseline Through Follow-Up
CRP assessed by commercial lab (LabCorp).
Time frame: Baseline, Month 4, 12, and 24
Mean Change in Interleukin (IL) IL-6 From Baseline Through Follow-Up
Assessed by independent lab blinded to participant arm.
Time frame: Baseline, Month 4, 12, and 24
Mean Change in Tumor Necrosis Factor (TNF) TNF-alpha From Baseline Through Follow-Up
Assessed by independent lab blinded to participant arm.
Time frame: Baseline, Month 4, 12, and 24
Mean Change in Skin Carotenoids From Baseline Through Follow-Up
Evaluated as the sum of 3 measures assessed by veggie-meter by Longevity Link Corporation. The Veggie Meter produces a score from 0 to 800, with higher scores indicating greater skin carotenoid levels, which suggest a greater intake of fruits and vegetables.
Time frame: Baseline, Month 4, 12, and 24
Mean Change in Quality of Life Scale From Baseline Through Follow-Up
The Euro Quality of Life Three Dimensions Questionnaire EQ-5D-3L ( EuroQol five-dimensional three-level questionnaire) scale measures patients' quality of healthy living. It has 5 items (Mobility, Self-care, Usual activities, Pain/discomfort, Depression/anxiety). Each item contains 3 levels: 1=no problems; 2=some problems; 3=extreme problems. The higher the score has the worse the health. Then, the score calculation of the European Five-Dimensional Health Scale is based on the calculation formula published for U.S. populations. Based on 3 combinations of different severity for the 5 items, a score of 0 to 1 is obtained which is called the EQ-5D-3L index and reported here. 0 is the least healthy and 1 is the most healthy.
Time frame: Baseline, Month 4, 12, and 24
Mean Change in Alternate Healthy Eating Index (AHEI)-2010 From Baseline Through Follow-Up
The AHEI-2010 is calculated from items on the Willett Food Frequency Questionnaire. It addresses intake of foods and nutrients consistently associated with lower risk for chronic diseases in the literature. The AHEI-2010 score is comprised of 11 sub-scales, each scored from 0 to 10, yielding a total score with a range of 0-110. A higher score indicates a more healthful dietary pattern.
Time frame: Baseline, Month 4, 12, and 24
Mean Change in Global Physical Activity Questionnaire (GPAQ) From Baseline Through Follow-Up
The GPAQ was developed by the World Health Organization (WHO) for physical activity surveillance. It collects information on physical activity participation in three settings (or domains) as well as sedentary behavior. The domains are: activity at work, travel to and from places, and recreational activities. The summary measure will be the sum of all moderate and vigorous activity per week (measured in hours) for the domains mentioned with a higher score indicating more physical activity.
Time frame: Baseline, Month 4, 12, and 24
Mean Change in Weight Loss Self-Efficacy From Baseline Through Follow-Up
The Weight Efficacy Lifestyle Questionnaire Short-Form (WEL-SF1) is a short version of the original Weight-Efficacy Lifestyle Questionnaire and includes 8 questions and 1 situational component representing "confidence in ability to resist eating." Three of the questions are related to emotional eating situations, two to availability, one to social pressure, one to positive activities, and one to physical discomfort. Scoring: The instrument range scores on a Likert-scale from 0 (not at all confident) to 10 (very confident), with sum scores between 0 and 80. High scores are associated with high eating self-efficacy.
Time frame: Baseline, Month 4, 12, and 24
Mean Change in Dietary Self-Regulation From Baseline Through Follow-Up
Treatment Self-regulation Questionnaire (TSRQ) measures the quality of motivation for a particular health goal. Motivation is psychological energy directed at a particular goal such as weight loss. The autonomous self-regulation sub-scale of the TSRQ was used.This 6-item scale will focus on the reasons why people would either start eating a healthier diet or continue to do so. Scoring: Participants rate each statement on a 7-point Likert scale ranging from 1 (not at all true) to 7 (very true). It assesses the degree to which a person's motivation for eating a healthy diet is autonomous or self-determined. Possible scores range from 6 to 42 wtih higher scores indicating greater motivation.
Time frame: Baseline, Month 4, 12, and 24
Mean Change in Eating Attitudes From Baseline Through Follow-Up (Cognitive Restraint)
The Cognitive Restraint subscale of the Three Factor Eating Questionnaire has 6 items and measures one of the three dimensions of eating attitudes. The instrument scoring range for each item is based on a Likert-scale from 1 (definitely false) to 4 (definitely true) with scores ranging from 6 and 24. Higher scores indicate greater cognitive restraint.
Time frame: Baseline, Month 4, 12, and 24
Mean Change in Eating Attitudes From Baseline Through Follow-Up (Uncontrolled Eating)
The uncontrolled eating subscale of the Three Factor Eating Questionnaire has 9 items and measures one of the three dimensions of eating attitudes. The instrument scoring range for each item is based on a Likert-scale from 1 (definitely false) to 4 (definitely true) with scores ranging from 9 and 36. Higher scores indicate greater uncontrolled eating.
Time frame: Baseline, Month 4, 12, and 24
Mean Change in Eating Attitudes From Baseline Through Follow-Up (Emotional Eating)
The emotional eating subscale of the Three Factor Eating Questionnaire has 3 items and measures one of the three dimensions of eating attitudes. The instrument scoring range for each item is based on a Likert-scale from 1 (definitely false) to 4 (definitely true) with scores ranging from 3 and 12. Higher scores indicate greater emotional eating.
Time frame: Baseline, Month 4, 12, and 24
Mean Change in Diet Self-Efficacy From Baseline Through Follow-Up
Perceived self-efficacy is regarded as a suitable predictor of reported health behaviors. This 5-item scale of perceived self-efficacy measures self-efficacy related to healthful eating behaviors. Responses are on a 4-point scale of 'very uncertain' to 'very certain.' Total scores range from 5-20 with higher scores indicating higher perceived self-efficacy.
Time frame: Baseline, Month 4, 12, and 24
Mean Change in Self-Weighing Behaviors From Baseline Through Follow-Up
EARLY Self-Weighing Questionnaire: This is a 1-item screener measures frequency of self-weighing. It was adapted from the Pound of Prevention Health Habits Questionnaire. Those reporting a higher weighing frequency had greater 24-month weight loss or less weight gain. Scoring: Higher scores indicate higher frequency of self-weighing. Responses are based on a 7-point scale ranging from 1 = never; 2 = once a year or less; 3= every couple of months; 4 = about once a month; 5 = about once a week; 6 = about once a day; and 7 = more than once a day.
Time frame: Baseline, Month 4, 12, and 24
Economic Outcome--Incremental Cost-Effectiveness
Computed as the incremental cost per kilogram of weight loss relative to control. The budgetary assessment will quantify the total and per participant costs of intervention delivery from the health system perspective using an Activity Based Costing (ABC) approach and cost tracking forms that the health economist (Finkelstein) has developed and refined in past behavioral trials. Using this approach, all relevant labor, materials and supplies, contracted services, and other relevant costs required to deliver the interventions will be captured by key activities
Time frame: Month 24
Economic Outcome--Incremental Cost Per Quality Adjusted Life Year (QALY) Gained
The numerator for this analysis will be the incremental program delivery costs of the intervention relative to control, minus any cost offsets based on differences in health services and medication use across arms. The denominator will be the incremental QALYs based on average differences in Euro Quality of Life five Dimensions Questionnaire (EQ-5D-5L) scores across arms collected at each assessment point. These scores can be used to quantify net QALY differences during the intervention period. EQ-5D-5L scale measures patients' quality of healthy living. It has 5 items (Mobility, Self-care, Usual activities, Pain/discomfort, Depression/anxiety). The score calculation of the European Five-Dimensional Health Scale is based on the calculation formula published by the EuroQol Group. Based on 5 combinations of different severity levels, a score of 0 to 1 is obtained. 0 is the least healthy and 1 is the most healthy.
Time frame: Month 24
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