Optimizing Adaptive Intensive Behavioral Therapy for Obesity During the Transition to Older Adulthood: A Sequential Multiple Assignment Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Change in Body Weight
研究概览
简要总结
To test adaptive intensive behavioral therapy strategies comprising dietary patterns with varying amounts of protein and including supplemental protein or resistance exercise training for promoting weight loss and attenuating lean mass loss in adults aged 50-75 with obesity.
详细描述
This Sequential Multiple Assignment Randomized Trial (SMART) seeks to identify the optimal initial dietary strategy (high vs. standard protein diets) and as-needed augmentation strategy (protein supplementation vs. supervised resistance exercise training) for behavioral weight loss in adults aged 50-75. Augmentation strategies will only be used for participants who do not achieve at least 3% weight loss and/or those who lose more than 1.5 kg of fat free mass (i.e., Non-Responders) after 8 weeks of group-based behavioral obesity treatment. Protein supplements and supervised resistance exercise training will be provided at no-cost to participants for weeks 9-16 of the study. Responders (i.e., achieving at least 3% weight loss and less than 1.5 kg loss of fat free mass) will continue with their initial high protein or standard protein diet assignment for the remainder of the trial. This SMART will enroll 250 adults aged 50-75 years with a BMI of at least 30 kg/m2. All participants will receive 1 year of behavioral obesity treatment including 16 weeks of weekly group-based treatment (active weight loss phase) followed by 36 weeks of monthly group sessions to promote continued engagement in dietary and exercise behaviors and long-term weight loss maintenance. The behavioral intervention will be delivered via Zoom. Data collection will occur at the University of Alabama at Birmingham and 5 study visits will be scheduled including: screening (to determine eligibility), prior to starting the weight loss intervention (baseline), and at weeks 8, 16, and 52.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female sex
- •all racial and ethnic groups
- •BMI: 30-50 kg/m2
- •age 50-75 years
- •postmenopausal status for ≥1 y if female sex
排除标准
- •<3 months stable use of other medications affecting body weight or appetite
- •>450 pounds (due to weight limitations of the DXA)
- •indication or previous diagnosis of sarcopenia
- •existing kidney disease
- •current binge eating disorder, anorexia, or bulimia
- •untreated hyper- or hypothyroidism, cancer (except basal cell), gastrointestinal disorders affecting food intake or nutrient absorption; any other medical condition, as determined by the study physician, precluding a HP diet and/or daily exercise
研究组 & 干预措施
High Protein Diet Only
Enrollment in State of Slim (SOS) weight loss program with a high protein diet. This arm includes participants identified as responders to the high protein diet counseling in stage 1 at the week 8 assessment.
干预措施: High Protein Diet Counceling (Behavioral)
High Protein Diet + Supplement
Enrollment in State of Slim (SOS) weight loss program with a high protein diet. Participants identified as non-responders at the week 8 assessment will receive protein supplements to augment their intervention plan.
干预措施: Protein Supplement (Behavioral)
High Protein Diet + Supervised Exercise
Enrollment in State of Slim (SOS) weight loss program with a high protein diet. Participants identified as non-responders at the week 8 assessment will receive supervised resistance training sessions to augment their intervention plan.
干预措施: High Protein Diet Counceling (Behavioral)
High Protein Diet + Supplement
Enrollment in State of Slim (SOS) weight loss program with a high protein diet. Participants identified as non-responders at the week 8 assessment will receive protein supplements to augment their intervention plan.
干预措施: High Protein Diet Counceling (Behavioral)
Standard Protein Diet + Supplement
Enrollment in State of Slim (SOS) weight loss program with a standard protein diet. Participants identified as non-responders at the week 8 assessment will receive protein supplements to augment their intervention plan.
干预措施: Protein Supplement (Behavioral)
Standard Protein Diet + Supervised Exercise
Enrollment in State of Slim (SOS) weight loss program with a standard protein diet. Participants identified as non-responders at the week 8 assessment will receive supervised resistance training sessions to augment their intervention plan.
干预措施: Standard Protein Diet Counceling (Behavioral)
Standard Protein Diet + Supervised Exercise
Enrollment in State of Slim (SOS) weight loss program with a standard protein diet. Participants identified as non-responders at the week 8 assessment will receive supervised resistance training sessions to augment their intervention plan.
干预措施: Supervised Exercise (Behavioral)
High Protein Diet + Supervised Exercise
Enrollment in State of Slim (SOS) weight loss program with a high protein diet. Participants identified as non-responders at the week 8 assessment will receive supervised resistance training sessions to augment their intervention plan.
干预措施: Supervised Exercise (Behavioral)
Standard Protein Diet Only
Enrollment in State of Slim (SOS) weight loss program with a standard protein diet. This arm includes participants identified as responders to the standard protein diet counseling in stage 1 at the week 8 assessment.
干预措施: Standard Protein Diet Counceling (Behavioral)
Standard Protein Diet + Supplement
Enrollment in State of Slim (SOS) weight loss program with a standard protein diet. Participants identified as non-responders at the week 8 assessment will receive protein supplements to augment their intervention plan.
干预措施: Standard Protein Diet Counceling (Behavioral)
结局指标
主要结局
Change in Body Weight
时间窗: Baseline, 8 weeks, 16 weeks, 52 weeks
Participants will be weighed at baseline through 52 weeks
Change in Fat Free Mass
时间窗: Baseline, 8 weeks, 16 weeks, 52 weeks
Participants will be scanned via DXA scan to measure overall fat free body mass
次要结局
- Change in Fat Mass(Baseline, 8 weeks, 16 weeks, 52 weeks)
- Change in Fasting Glucose(Baseline, 8 weeks, 16 weeks, 52 weeks)
- Change in Fasting Insulin(Baseline, 8 weeks, 16 weeks, 52 weeks)
- Change in Fasting Hemoglobin A1C(Baseline, 8 weeks, 16 weeks, 52 weeks)
- Change in Fasting LDL-cholesterol(Baseline, 8 weeks, 16 weeks, 52 weeks)
- Change in Fasting HDL-cholesterol(Baseline, 8 weeks, 16 weeks, 52 weeks)
- Change in Fasting Total Cholesterol(Baseline, 8 weeks, 16 weeks, 52 weeks)
- Change in Fasting Total Triglycerides(Baseline, 8 weeks, 16 weeks, 52 weeks)
- Change in Blood Pressure(Baseline, 8 weeks, 16 weeks, 52 weeks)
- Change in Hand Grip Strength(Baseline, 8 weeks, 16 weeks, 52 weeks)
- Change in Lower Extremity Strength(Baseline, 8 weeks, 16 weeks, 52 weeks)
研究者
Drew Sayer
Assistant Professor
University of Alabama at Birmingham