Clinical trial NCT04302727: Delicious Eating for Life in Southern Homes
Official title: Randomized Explanatory Trial of a Mediterranean Dietary Pattern Weight Loss Intervention for Primary Care Practices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Diet, Healthy
Cardiovascular Risk Factor
Keywords: Behavioral weight loss
Mediterranean dietary pattern
Lifestyle program
Inflammatory markers
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-03-10
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean Weight Change from Baseline to Month 24
timeFrame: Baseline, Month 24
Secondary outcomes:
measure: Mean Weight Change from Baseline to Months 4 and 12
timeFrame: Baseline, Months 4 and 12
measure: Mean Weight Change from Baseline through Follow-Up by Sub-Groups
timeFrame: Baseline, Months 4, 12, and 24
measure: Percentage Weight from Baseline through Follow-Up
timeFrame: Baseline, Months 4, 12, and 24
measure: Mean Change in Systolic Blood Pressure from Baseline through Follow-Up
timeFrame: Baseline, Months 4, 12, and 24
measure: Mean Change in Diastolic Blood Pressure from Baseline through Follow-Up
timeFrame: Baseline, Months 4, 12, and 24
measure: Mean Change in Total Cholesterol from Baseline through Follow-Up
timeFrame: Baseline, Month 4, 12, and 24
measure: Mean Change in HDL-Cholesterol from Baseline through Follow-Up
timeFrame: Baseline, Month 4, 12, and 24
measure: Mean Change in Triglycerides from Baseline through Follow-Up
timeFrame: Baseline, Month 4, 12, and 24
measure: Mean Change LDL-cholesterol from Baseline through Follow-up
timeFrame: Baseline, Month 4, 12, and 24
measure: Mean Change in A1c from Baseline through Follow-Up
timeFrame: Baseline, Month 4, 12, and 24
measure: Mean Change in CRP from Baseline through Follow-Up
timeFrame: Baseline, Month 4, 12, and 24
measure: Mean Change in IL-6 from Baseline through Follow-Up
timeFrame: Baseline, Month 4, 12, and 24
measure: Mean Change in TNF-alpha from Baseline through Follow-Up
timeFrame: Baseline, Month 4, 12, and 24
measure: Mean Change in Skin Carotenoids from Baseline through Follow-Up
timeFrame: Baseline, Month 4, 12, and 24
measure: Mean Change in Quality of Life Scale from Baseline through Follow-Up
timeFrame: Baseline, Month 4, 12, and 24
measure: Mean Change in Alternate Healthy Eating Index (AHEI)-2010 from Baseline through Follow-Up
timeFrame: Baseline, Month 4, 12, and 24
measure: Mean Change in Global Physical Activity Questionnaire (GPAQ) from Baseline through Follow-Up
timeFrame: Baseline, Month 4, 12, and 24
measure: Mean Change in Weight Loss Self-Efficacy from Baseline through Follow-Up
timeFrame: Baseline, Month 4, 12, and 24
measure: Mean Change in Dietary Self-Regulation from Baseline through Follow-Up
timeFrame: Baseline, Month 4, 12, and 24
measure: Mean Change in Eating Attitudes from Baseline through Follow-Up
timeFrame: Baseline, Month 4, 12, and 24
measure: Mean Change in Diet Self-Efficacy from Baseline through Follow-Up
timeFrame: Baseline, Month 4, 12, and 24
measure: Mean Change in Self-Weighing Behaviors from Baseline through Follow-Up
timeFrame: Baseline, Month 4, 12, and 24
measure: Economic Outcome--Incremental Cost-Effectiveness
timeFrame: Month 24
measure: Economic Outcome--Incremental Cost per Quality Adjusted Life Year (QALY) gained
timeFrame: Month 24
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Center for Health Promotion and Disease Prevention
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Carmen D Samuel-Hodge, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Thomas C Keyserling, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Keyserling TC, Samuel-Hodge CD, Pitts SJ, Garcia BA, Johnston LF, Gizlice Z, Miller CL, Braxton DF, Evenson KR, Smith JC, Davis GB, Quenum EL, Elliott NT, Gross MD, Donahue KE, Halladay JR, Ammerman AS. A community-based lifestyle and weight loss intervention promoting a Mediterranean-style diet pattern evaluated in the stroke belt of North Carolina: the Heart Healthy Lenoir Project. BMC Public Health. 2016 Aug 5;16:732. doi: 10.1186/s12889-016-3370-9.
citation: Keyserling TC, Samuel Hodge CD, Jilcott SB, Johnston LF, Garcia BA, Gizlice Z, Gross MD, Savinon CE, Bangdiwala SI, Will JC, Farris RP, Trost S, Ammerman AS. Randomized trial of a clinic-based, community-supported, lifestyle intervention to improve physical activity and diet: the North Carolina enhanced WISEWOMAN project. Prev Med. 2008 Jun;46(6):499-510. doi: 10.1016/j.ypmed.2008.02.011. Epub 2008 Feb 15.
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citation: Embree GG, Samuel-Hodge CD, Johnston LF, Garcia BA, Gizlice Z, Evenson KR, DeWalt DA, Ammerman AS, Keyserling TC. Successful long-term weight loss among participants with diabetes receiving an intervention promoting an adapted Mediterranean-style dietary pattern: the Heart Healthy Lenoir Project. BMJ Open Diabetes Res Care. 2017 Mar 29;5(1):e000339. doi: 10.1136/bmjdrc-2016-000339. eCollection 2017.
citation: Samuel-Hodge CD, Holder-Cooper JC, Gizlice Z, Davis G, Steele SP, Keyserling TC, Kumanyika SK, Brantley PJ, Svetkey LP. Family PArtners in Lifestyle Support (PALS): Family-based weight loss for African American adults with type 2 diabetes. Obesity (Silver Spring). 2017 Jan;25(1):45-55. doi: 10.1002/oby.21700. Epub 2016 Dec 2.
citation: Samuel-Hodge CD, Garcia BA, Johnston LF, Gizlice Z, Ni A, Cai J, Kraschnewski JL, Gustafson AA, Norwood AF, Glasgow RE, Gold AD, Graham JW, Evenson KR, Trost S, Keyserling TC. Translation of a behavioral weight loss intervention for mid-life, low-income women in local health departments. Obesity (Silver Spring). 2013 Sep;21(9):1764-73. doi: 10.1002/oby.20317. Epub 2013 May 24.
citation: Samuel-Hodge CD, Johnston LF, Gizlice Z, Garcia BA, Lindsley SC, Bramble KP, Hardy TE, Ammerman AS, Poindexter PA, Will JC, Keyserling TC. Randomized trial of a behavioral weight loss intervention for low-income women: the Weight Wise Program. Obesity (Silver Spring). 2009 Oct;17(10):1891-9. doi: 10.1038/oby.2009.128. Epub 2009 Apr 30.