Delicious Eating for Life in Southern Homes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Explanatory Trial of a Mediterranean Dietary Pattern Weight Loss Intervention for Primary Care Practices

Conditions
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Weight Loss, Diet, Healthy, Cardiovascular Risk Factor

Intervention / Treatment
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* Behavioral: Med-South Weight Loss Intervention
* Behavioral: WW


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Med-South Weight Loss Intervention<br>The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate. | Behavioral: Med-South Weight Loss Intervention<br>* 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.<br>* Other names: Delicious Eating for Life in Southern Homes (DELISH) Weight Loss Program;|
| Active Comparator: Augmented Usual Care (WW)<br>The intervention that will be offered to control group participants is WW™ (formerly known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention. | Behavioral: WW<br>* 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.<br>* Other names: Weight Watchers;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean 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. | Baseline, Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean 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. | Baseline, Months 4 and 12 | 
| Mean Weight Change 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. Change in weight will be assessed across 3 pre-specified subgroups: 1) with vs. without diabetes; 2) females vs. males; and 3) whites vs. African Americans. | Baseline, Months 4, 12, and 24 | 
| Percentage Weight from Baseline through Follow-Up | 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. | 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. | 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. | Baseline, Months 4, 12, and 24 | 
| Mean Change in Total Cholesterol from Baseline through Follow-Up | Total cholesterol assessed by commercial lab (LabCorp). | Baseline, Month 4, 12, and 24 | 
| Mean Change in HDL-Cholesterol from Baseline through Follow-Up | HDL-Cholesterol assessed by commercial lab (LabCorp). | Baseline, Month 4, 12, and 24 | 
| Mean Change in Triglycerides from Baseline through Follow-Up | Triglycerides as assessed by commercial lab (LabCorp). | Baseline, Month 4, 12, and 24 | 
| Mean Change LDL-cholesterol from Baseline through Follow-up | Calculated from above lipid assessments by commercial lab (LabCorp). | Baseline, Month 4, 12, and 24 | 
| Mean Change in A1c from Baseline through Follow-Up | A1c assessed by commercial lab (LabCorp). | Baseline, Month 4, 12, and 24 | 
| Mean Change in CRP from Baseline through Follow-Up | CRP assessed by commercial lab (LabCorp). | Baseline, Month 4, 12, and 24 | 
| Mean Change in IL-6 from Baseline through Follow-Up | Assessed by independent lab blinded to participant arm. | Baseline, Month 4, 12, and 24 | 
| Mean Change in TNF-alpha from Baseline through Follow-Up | Assessed by independent lab blinded to participant arm. | 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. | Baseline, Month 4, 12, and 24 | 
| Mean Change in Quality of Life Scale from Baseline through Follow-Up | The Euro Quality of Life five Dimensions Questionnaire EQ-5D-5L scale measures patients' quality of healthy living. It has 5 items (Mobility, Self-care, Usual activities, Pain/discomfort, Depression/anxiety). Each item contains 5 levels: 1= no difficulty, 2= slight difficulty, 3= moderate difficulty, 4= serious difficulty, 5= extremely serious difficulty. 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 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. | 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. | 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 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 activity per day with a higher score indication more physical activity. | 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. | 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. This measure assesses three types of motivation: autonomous self-regulation, controlled self-regulation, and a-motivation or lack of motivation. This 15-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. The three sub-scale scores can be used separately or a Relative Autonomous Motivation score can be calculated. A higher score indicates greater motivation. | Baseline, Month 4, 12, and 24 | 
| Mean Change in Eating Attitudes from Baseline through Follow-Up | The Three Factor Eating Questionnaire (18 item revised version) measures eating attitudes with scales representing three dimensions of eating behavior: cognitive restraint (control over food intake in order to influence body weight / body shape), uncontrolled eating (loss of control over eating), and emotional eating (eating in response to positive and negative emotions). Scoring: Each scale (dimension) is scored separately. Six of the eighteen items measure cognitive restraint, nine measure uncontrolled eating, and three measure emotional eating. Higher scores indicate greater cognitive restraint. | 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 behavioral intentions and reported health behaviors. This 5-item scale of perceived self-efficacy measuring action self-efficacy and coping self-efficacy related to healthful eating behaviors. Responses are on a 4-point scale of 'very uncertain' to 'very certain.' Scoring: Higher scores indicate higher perceived self-efficacy. Validation: Evidence for the validity of the scales has been published in several articles. Cronbach's alpha for the nutrition self-efficacy measure ranges from 0.79 to 0.85. | Baseline, Month 4, 12, and 24 | 
| Mean Change in Self-Weighing Behaviors from Baseline through Follow-Up | EARLY Self-Weighing Questionnaire: This is a 2-item screener measures frequency of self-weighing and access to a bathroom scale. It was adapted from the Pound of Prevention Health Habits Questionnaire, Year 2. Validity of construct confirmed in Linde et al, 2005, as reports of higher weighing frequency was associated with greater 24-month weight loss or less weight gain. Scoring: Higher scores indicate higher frequency of self-weighing and access to a bathroom scale. | 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 | 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. | Month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioral weight loss, Mediterranean dietary pattern, Lifestyle program, Inflammatory markers