Randomized Explanatory Trial of a Mediterranean Dietary Pattern Weight Loss Intervention for Primary Care Practices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Percent Weight Change From Baseline to Month 24
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Percent Weight Change From Baseline to Month 24
时间窗: 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.
次要结局
- Economic Outcome--Incremental Cost-Effectiveness(Month 24)
- 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)
- Mean Change in Total Cholesterol From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change in HDL-Cholesterol From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change in Triglycerides From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change LDL-cholesterol From Baseline Through Follow-up(Baseline, Month 4, 12, and 24)
- Mean Change in A1c From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change in CRP (C-Reactive Protein) From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change in Interleukin (IL) IL-6 From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change in Tumor Necrosis Factor (TNF) TNF-alpha From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change in Skin Carotenoids From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change in Quality of Life Scale From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change in Alternate Healthy Eating Index (AHEI)-2010 From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change in Global Physical Activity Questionnaire (GPAQ) From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change in Weight Loss Self-Efficacy From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change in Dietary Self-Regulation From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change in Eating Attitudes From Baseline Through Follow-Up (Cognitive Restraint)(Baseline, Month 4, 12, and 24)
- Mean Change in Eating Attitudes From Baseline Through Follow-Up (Uncontrolled Eating)(Baseline, Month 4, 12, and 24)
- Mean Change in Eating Attitudes From Baseline Through Follow-Up (Emotional Eating)(Baseline, Month 4, 12, and 24)
- Mean Change in Diet Self-Efficacy From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Mean Change in Self-Weighing Behaviors From Baseline Through Follow-Up(Baseline, Month 4, 12, and 24)
- Economic Outcome--Incremental Cost-Effectiveness(Month 24)
- Economic Outcome--Incremental Cost Per Quality Adjusted Life Year (QALY) Gained(Month 24)