Pilot Trial of a Scalable Behavioral Program for Weight Loss Maintenance After GLP-1 and Anti-Obesity Medication Discontinuation
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Percentage of participants retention
概览
简要总结
This study is a single-site, pilot randomized factorial trial designed to evaluate the feasibility, acceptability, participant perceptions and preliminary effects of a multi-component behavioral intervention to support weight loss maintenance following discontinuation of GLP-1 and other anti-obesity medications. The intervention includes a standardized 10-week foundational weight loss maintenance program combined with candidate support components, including medically tailored meals, YMCA membership, and a structured mind-based program. Participants will be randomized using a 2 × 2 × 2 factorial design and followed for six months. Findings from this pilot study will inform optimization of a scalable intervention for future clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Loss of ≥15% of initial body weight using anti-obesity medication
- •Discontinued anti-obesity medication within the past 4 weeks or planning to discontinue prior to randomization
- •≤3 kg weight regain within the past 3 months
- •Willing and able to participate in a 6-month behavioral intervention, including a 10-week foundational program
- •Willing to complete study assessments at baseline, 3 months, and 6 months, including required in-person visits
- •Medical clearance for participation in moderate physical activity, dietary modification, and mind-based practices
- •Access to reliable internet for participation in virtual sessions and remote data collection
- •English fluency sufficient to complete study procedures
- •Able to provide informed consent
排除标准
- •Medical conditions that would preclude safe participation in physical activity, dietary changes, or mind-based practices (e.g., unstable cardiovascular disease, uncontrolled hypertension, severe orthopedic limitations, or seizure disorders not medically managed)
- •Active psychiatric conditions that would interfere with participation or safety (e.g., untreated major depression, active substance use disorder, or psychosis)
- •Pregnancy, breastfeeding, or plans to become pregnant during the study period
- •Current participation in another structured weight loss or weight maintenance program
- •Continued use of anti-obesity medication after randomization
- •Plans to initiate medications or treatments that may significantly affect body weight during the study period
- •Inability to attend required study visits or participate in virtual sessions and remote data collection
- •Any condition that, in the opinion of the investigators, would compromise participant safety or study integrity
研究组 & 干预措施
Group 7: WLM Program + SKY
Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive support components: (3) the SKY Meditation program to support mind-based practices.
干预措施: SKY Meditation Program (Behavioral)
Group 1: WLM Program + Mom's Meals + YMCA + SKY
Eight participants will be assigned to the foundational WLM program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive three candidate support components: (1) medically tailored meals (Mom's Meals), (2) YMCA membership to support physical activity, and (3) the SKY Meditation program to support mind-based practices.
干预措施: Weight Loss Maintenance Program (Foundational) (Behavioral)
Group 1: WLM Program + Mom's Meals + YMCA + SKY
Eight participants will be assigned to the foundational WLM program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive three candidate support components: (1) medically tailored meals (Mom's Meals), (2) YMCA membership to support physical activity, and (3) the SKY Meditation program to support mind-based practices.
干预措施: Mom's Meals (Behavioral)
Group 1: WLM Program + Mom's Meals + YMCA + SKY
Eight participants will be assigned to the foundational WLM program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive three candidate support components: (1) medically tailored meals (Mom's Meals), (2) YMCA membership to support physical activity, and (3) the SKY Meditation program to support mind-based practices.
干预措施: YMCA Membership (Behavioral)
Group 1: WLM Program + Mom's Meals + YMCA + SKY
Eight participants will be assigned to the foundational WLM program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive three candidate support components: (1) medically tailored meals (Mom's Meals), (2) YMCA membership to support physical activity, and (3) the SKY Meditation program to support mind-based practices.
干预措施: SKY Meditation Program (Behavioral)
Group 2: WLM Program + Mom's Meals + YMCA
Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive two candidate support components: (1) medically tailored meals (Mom's Meals), (2) YMCA membership to support physical activity.
干预措施: Weight Loss Maintenance Program (Foundational) (Behavioral)
Group 2: WLM Program + Mom's Meals + YMCA
Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive two candidate support components: (1) medically tailored meals (Mom's Meals), (2) YMCA membership to support physical activity.
干预措施: Mom's Meals (Behavioral)
Group 2: WLM Program + Mom's Meals + YMCA
Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive two candidate support components: (1) medically tailored meals (Mom's Meals), (2) YMCA membership to support physical activity.
干预措施: YMCA Membership (Behavioral)
Group 3: WLM Program + Mom's Meals + SKY
Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive candidate support components: (1) medically tailored meals (Mom's Meals), and (3) the SKY Meditation program to support mind-based practices.
干预措施: Weight Loss Maintenance Program (Foundational) (Behavioral)
Group 3: WLM Program + Mom's Meals + SKY
Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive candidate support components: (1) medically tailored meals (Mom's Meals), and (3) the SKY Meditation program to support mind-based practices.
干预措施: Mom's Meals (Behavioral)
Group 3: WLM Program + Mom's Meals + SKY
Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive candidate support components: (1) medically tailored meals (Mom's Meals), and (3) the SKY Meditation program to support mind-based practices.
干预措施: SKY Meditation Program (Behavioral)
Group 4: WLM Program + Mom's Meals
Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive candidate support components: (1) medically tailored meals (Mom's Meals).
干预措施: Weight Loss Maintenance Program (Foundational) (Behavioral)
Group 4: WLM Program + Mom's Meals
Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive candidate support components: (1) medically tailored meals (Mom's Meals).
干预措施: Mom's Meals (Behavioral)
Group 5: WLM Program + YMCA + SKY
Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive candidate support components: (2) YMCA membership to support physical activity, and (3) the SKY Meditation program to support mind-based practices.
干预措施: Weight Loss Maintenance Program (Foundational) (Behavioral)
Group 5: WLM Program + YMCA + SKY
Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive candidate support components: (2) YMCA membership to support physical activity, and (3) the SKY Meditation program to support mind-based practices.
干预措施: YMCA Membership (Behavioral)
Group 5: WLM Program + YMCA + SKY
Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive candidate support components: (2) YMCA membership to support physical activity, and (3) the SKY Meditation program to support mind-based practices.
干预措施: SKY Meditation Program (Behavioral)
Group 6: WLM Program + YMCA
Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive support components: (2) YMCA membership to support physical activity.
干预措施: Weight Loss Maintenance Program (Foundational) (Behavioral)
Group 6: WLM Program + YMCA
Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive support components: (2) YMCA membership to support physical activity.
干预措施: YMCA Membership (Behavioral)
Group 7: WLM Program + SKY
Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive support components: (3) the SKY Meditation program to support mind-based practices.
干预措施: Weight Loss Maintenance Program (Foundational) (Behavioral)
Group 8: Foundational WLM Program Only
Eight participants will receive the 10-week foundational program. One group (n=8) will receive only the foundational program without any additional components.
干预措施: Weight Loss Maintenance Program (Foundational) (Behavioral)
结局指标
主要结局
Percentage of participants retention
时间窗: 3 months, 6 months,
Retention will be calculated as the proportion of randomized participants completing the 3- and 6-month follow-up assessments. For the proposed study, retention rates ≥80% over the 6-month intervention period would indicate the study is feasible as-is. If retention is \<80%, we will consider modifications to the study design and dedication of greater resources towards improving retention in the full-scale factorial trial.
Percentage of participants that adhered to the 10-week foundational support sessions
时间窗: 10 weeks
Adherence to the 10-week foundational support sessions will be measured as the percentage of attended sessions relative to scheduled sessions. For the proposed study, the feasibility benchmark for adherence was set at ≥80% attendance. If adherence is \<80%, we will consider modifications to the study design and dedication of greater resources towards improving adherence in the full-scale factorial trial. The other measures of adherence will be evaluated with descriptive statistics. Completion rates of weekly logs for food intake, physical activity, and mind-based practices will be documented and tracked in REDCap. Additionally, daily usage of Garmin scales and fitness trackers will be monitored, with rates of adherence assessed as the percentage of days that participants engage with these devices.
次要结局
- Overall Weight Loss Maintenance without medication(Baseline, 3 months, 6 moths)
研究者
Holly Wyatt
Professor
University of Alabama at Birmingham