Delicious Eating for Life in Southern Homes

NCT04302727 | Completed Results DMC

• 4 other identifiers: 19-17121R61HL142680-01A14R33HL142680-025R33HL142680-03
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss; Diet, Healthy; Cardiovascular Risk Factor

Keywords

Behavioral weight loss; Mediterranean dietary pattern; Lifestyle program; Inflammatory markers

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Month 24

Secondary Outcomes (26)

• 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

Study Arms (2)

Med-South Weight Loss Intervention

EXPERIMENTAL

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

Augmented Usual Care (WW)

ACTIVE COMPARATOR

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

Interventions

Med-South Weight Loss Intervention BEHAVIORAL

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.

Also known as: Delicious Eating for Life in Southern Homes (DELISH) Weight Loss Program

Med-South Weight Loss Intervention

WW BEHAVIORAL

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.

Also known as: Weight Watchers

Augmented Usual Care (WW)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UNC Center for Health Promotion and Disease Prevention

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (8)

• 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.

  PMID: 27495295 BACKGROUND

• 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.

  PMID: 18394692 BACKGROUND

• Keyserling TC, Sheridan SL, Draeger LB, Finkelstein EA, Gizlice Z, Kruger E, Johnston LF, Sloane PD, Samuel-Hodge C, Evenson KR, Gross MD, Donahue KE, Pignone MP, Vu MB, Steinbacher EA, Weiner BJ, Bangdiwala SI, Ammerman AS. A comparison of live counseling with a web-based lifestyle and medication intervention to reduce coronary heart disease risk: a randomized clinical trial. JAMA Intern Med. 2014 Jul;174(7):1144-57. doi: 10.1001/jamainternmed.2014.1984.

  PMID: 24861959 BACKGROUND

• 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.

  PMID: 28405344 BACKGROUND

• 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.

  PMID: 27911049 BACKGROUND

• 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.

  PMID: 23408464 BACKGROUND

• 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.

  PMID: 19407810 BACKGROUND

• Saraiya VM, Berkowitz SA, Johnston LF, Couper DJ, Sotres-Alvarez D, Lyons KM, Thaxton CK, Skinner HG, Samuel-Hodge CD, Keyserling TC. An Evaluation of Primary Care Clinician Referrals for Behavioral Weight Loss Counseling. J Prim Care Community Health. 2024 Jan-Dec;15:21501319241308054. doi: 10.1177/21501319241308054.

  PMID: 39690977 DERIVED

MeSH Terms

Conditions

Weight Loss

Interventions

Weight Reduction Programs

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Promotion; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Thomas Keyserling, MD
• Organization: University of North Carolina at Chapel Hill

thomas_keyserling@med.unc.edu

984-974-4462

Study Officials

• Carmen D Samuel-Hodge, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Thomas C Keyserling, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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 Committee
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 10, 2020
• Study Start: July 6, 2020
• Primary Completion: June 16, 2024
• Study Completion: June 16, 2024
• Last Updated: November 3, 2025
• Results First Posted: November 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 9 to 36 months following publication
• Access Criteria: Approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.

Locations

US (1)