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Delicious Eating for Life in Southern Homes (DELISH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04302727
Recruitment Status : Suspended (Recruitment has been suspended due to COVID-19.)
First Posted : March 10, 2020
Last Update Posted : May 1, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Weight Loss Diet, Healthy Cardiovascular Risk Factor Behavioral: Med-South Weight Loss Intervention Behavioral: WW Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Masking Description: 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
Primary Purpose: Treatment
Official Title: Randomized Explanatory Trial of a Mediterranean Dietary Pattern Weight Loss Intervention for Primary Care Practices
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Med-South Weight Loss Intervention
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
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.
Other Name: Delicious Eating for Life in Southern Homes (DELISH) Weight Loss Program

Active Comparator: Augmented Usual Care (WW)
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
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.
Other Name: Weight Watchers




Primary Outcome Measures :
  1. Mean 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 Outcome Measures :
  1. Mean Weight Change from Baseline to Months 4 and 12 [ Time Frame: Baseline, 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.

  2. Mean Weight Change from Baseline through Follow-Up by Sub-Groups [ Time Frame: Baseline, Months 4, 12, and 24 ]
    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.

  3. Percentage Weight from Baseline through Follow-Up [ Time Frame: Baseline, Months 4, 12, and 24 ]
    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.

  4. Mean Change in Systolic Blood Pressure from Baseline through Follow-Up [ Time Frame: Baseline, Months 4, 12, and 24 ]
    Blood pressure assessed by Omron-907xl, average of 3 readings.

  5. Mean Change in Diastolic Blood Pressure from Baseline through Follow-Up [ Time Frame: Baseline, Months 4, 12, and 24 ]
    Blood pressure assessed by Omron-907xl, average of 3 readings.

  6. Mean Change in Total Cholesterol from Baseline through Follow-Up [ Time Frame: Baseline, Month 4, 12, and 24 ]
    Total cholesterol assessed by commercial lab (LabCorp).

  7. Mean Change in HDL-Cholesterol from Baseline through Follow-Up [ Time Frame: Baseline, Month 4, 12, and 24 ]
    HDL-Cholesterol assessed by commercial lab (LabCorp).

  8. Mean Change in Triglycerides from Baseline through Follow-Up [ Time Frame: Baseline, Month 4, 12, and 24 ]
    Triglycerides as assessed by commercial lab (LabCorp).

  9. Mean Change LDL-cholesterol from Baseline through Follow-up [ Time Frame: Baseline, Month 4, 12, and 24 ]
    Calculated from above lipid assessments by commercial lab (LabCorp).

  10. Mean Change in A1c from Baseline through Follow-Up [ Time Frame: Baseline, Month 4, 12, and 24 ]
    A1c assessed by commercial lab (LabCorp).

  11. Mean Change in CRP from Baseline through Follow-Up [ Time Frame: Baseline, Month 4, 12, and 24 ]
    CRP assessed by commercial lab (LabCorp).

  12. Mean Change in IL-6 from Baseline through Follow-Up [ Time Frame: Baseline, Month 4, 12, and 24 ]
    Assessed by independent lab blinded to participant arm.

  13. Mean Change in TNF-alpha from Baseline through Follow-Up [ Time Frame: Baseline, Month 4, 12, and 24 ]
    Assessed by independent lab blinded to participant arm.

  14. Mean Change in Skin Carotenoids from Baseline through Follow-Up [ Time Frame: Baseline, Month 4, 12, and 24 ]
    Evaluated as the sum of 3 measures assessed by veggie-meter by Longevity Link Corporation.

  15. Mean Change in Quality of Life Scale from Baseline through Follow-Up [ Time Frame: Baseline, Month 4, 12, and 24 ]
    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.

  16. Mean Change in Alternate Healthy Eating Index (AHEI)-2010 from Baseline through Follow-Up [ Time Frame: Baseline, Month 4, 12, and 24 ]
    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.

  17. Mean Change in Global Physical Activity Questionnaire (GPAQ) from Baseline through Follow-Up [ Time Frame: Baseline, Month 4, 12, and 24 ]
    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.

  18. Mean Change in Weight Loss Self-Efficacy from Baseline through Follow-Up [ Time Frame: Baseline, Month 4, 12, and 24 ]

    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.


  19. Mean Change in Dietary Self-Regulation from Baseline through Follow-Up [ Time Frame: Baseline, Month 4, 12, and 24 ]

    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.


  20. Mean Change in Eating Attitudes from Baseline through Follow-Up [ Time Frame: Baseline, Month 4, 12, and 24 ]

    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.


  21. Mean Change in Diet Self-Efficacy from Baseline through Follow-Up [ Time Frame: Baseline, Month 4, 12, and 24 ]

    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.


  22. Mean Change in Self-Weighing Behaviors from Baseline through Follow-Up [ Time Frame: Baseline, Month 4, 12, and 24 ]

    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.


  23. Economic Outcome--Incremental Cost-Effectiveness [ Time Frame: Month 24 ]

    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


  24. Economic Outcome--Incremental Cost per Quality Adjusted Life Year (QALY) gained [ Time Frame: Month 24 ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04302727


Locations
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United States, North Carolina
UNC Center for Health Promotion and Disease Prevention
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Carmen D Samuel-Hodge, PhD University of North Carolina, Chapel Hill
Principal Investigator: Thomas C Keyserling, MD University of North Carolina, Chapel Hill
Publications:

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04302727    
Other Study ID Numbers: 19-1712
1R61HL142680-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 10, 2020    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Supporting Materials: Study Protocol
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
Behavioral weight loss
Mediterranean dietary pattern
Lifestyle program
Inflammatory markers
Additional relevant MeSH terms:
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Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes