Optimizing a Weight Neutral Intervention to Improve Health Among Adults of Higher Body Weight: A MOST Preparation Phase Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Client Satisfaction Questionnaire
研究概览
简要总结
The purpose of this research study is to pilot test five different, group based and remotely delivered programs designed to support healthy eating and regular physical activity. Each group will contain information and support for healthy eating and physical activity. Groups may also include support to 1) eat with more awareness of hunger and fullness, 2) improve how people think and feel about their bodies, and/or 3) identify ways to be physically active that are more enjoyable. Each group will include a unique combination of these components and the goal is to assess overall satisfaction and engagement with each of the programs.
详细描述
The goal of study is to conduct a Multiphase Optimization STrategy (MOST) Preparation phase study to combine and pilot test candidate components for a group-based, remotely delivered weight neutral/healthy lifestyle intervention. Potential treatment components will include the following existing, evidence-based interventions; (1) mindfulness-based eating awareness training , (2) body acceptance program , and (3) a tailored intervention to promote enjoyment of physical activity. Weight neutral components will complement a Core intervention of standardized education on healthy diet (emphasizing the Mediterranean diet) and Physical Activity Guidelines for Americans (i.e., aerobic activity, muscle strengthening). This phase of the science is focused on pilot testing to ensure the target sample can be recruited and and that the novel combinations of treatment components can be delivered as intended. To make strategic use of resources, a fractional factorial design will be used to pilot test five conditions: the Core intervention alone and all possible combinations of the Core intervention + two or more of the weight neutral components. Men and women (n=50) with BMI≥25kg/m2 will be recruited and randomized in small groups (n=10) to receive one of the five conditions held online (each 12 weeks in duration).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years and older
- •BMI between 25-40 (if BMI is between 25-30 then additional cardiometabolic risk factor must be present including hypertension, high cholesterol, prediabetes or type 2 diabetes)
排除标准
- •current participation in a formal weight loss program
- •current use of weight loss medication
- •history of bariatric surgery
- •physical condition that would limit the ability to engage in moderate intensity physical activity
- •current pregnancy
- •recent weight loss of 5% body weight
- •condition that may interfere with ability to complete the study procedures
研究组 & 干预措施
Core Component
Participants in the Core component condition will receive guidance and support for healthy eating and regular physical activity.
干预措施: Mediterranean eating style (Behavioral)
Core Component
Participants in the Core component condition will receive guidance and support for healthy eating and regular physical activity.
干预措施: Physical activity (Behavioral)
Core Component+Mindful eating+Enjoyable exercise
Participants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive support to eat with more awareness of hunger and fullness signals and to explore/identify ways to enjoy physical activity.
干预措施: Mediterranean eating style (Behavioral)
Core Component+Mindful eating+Enjoyable exercise
Participants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive support to eat with more awareness of hunger and fullness signals and to explore/identify ways to enjoy physical activity.
干预措施: Physical activity (Behavioral)
Core Component+Mindful eating+Enjoyable exercise
Participants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive support to eat with more awareness of hunger and fullness signals and to explore/identify ways to enjoy physical activity.
干预措施: Mindful Eating (Behavioral)
Core Component+Mindful eating+Enjoyable exercise
Participants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive support to eat with more awareness of hunger and fullness signals and to explore/identify ways to enjoy physical activity.
干预措施: Enjoyable Exercise (Behavioral)
All component condition
Participants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive support to eat with more awareness of hunger and fullness signals, strategies to improve how they think and feel about their bodies, and to explore/identify ways to enjoy physical activity.
干预措施: Mediterranean eating style (Behavioral)
All component condition
Participants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive support to eat with more awareness of hunger and fullness signals, strategies to improve how they think and feel about their bodies, and to explore/identify ways to enjoy physical activity.
干预措施: Physical activity (Behavioral)
All component condition
Participants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive support to eat with more awareness of hunger and fullness signals, strategies to improve how they think and feel about their bodies, and to explore/identify ways to enjoy physical activity.
干预措施: Mindful Eating (Behavioral)
All component condition
Participants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive support to eat with more awareness of hunger and fullness signals, strategies to improve how they think and feel about their bodies, and to explore/identify ways to enjoy physical activity.
干预措施: Body Appreciation (Behavioral)
All component condition
Participants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive support to eat with more awareness of hunger and fullness signals, strategies to improve how they think and feel about their bodies, and to explore/identify ways to enjoy physical activity.
干预措施: Enjoyable Exercise (Behavioral)
Core Component+Mindful eating+Body Appreciation
Participants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive support to eat with more awareness of hunger and fullness signals and strategies to improve how they think and feel about their bodies.
干预措施: Mediterranean eating style (Behavioral)
Core Component+Mindful eating+Body Appreciation
Participants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive support to eat with more awareness of hunger and fullness signals and strategies to improve how they think and feel about their bodies.
干预措施: Physical activity (Behavioral)
Core Component+Mindful eating+Body Appreciation
Participants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive support to eat with more awareness of hunger and fullness signals and strategies to improve how they think and feel about their bodies.
干预措施: Mindful Eating (Behavioral)
Core Component+Mindful eating+Body Appreciation
Participants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive support to eat with more awareness of hunger and fullness signals and strategies to improve how they think and feel about their bodies.
干预措施: Body Appreciation (Behavioral)
Core component+body appreciation+enjoyment of exercise
Participants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive strategies to improve how they think and feel about their bodies, and to explore/identify ways to enjoy physical activity.
干预措施: Mediterranean eating style (Behavioral)
Core component+body appreciation+enjoyment of exercise
Participants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive strategies to improve how they think and feel about their bodies, and to explore/identify ways to enjoy physical activity.
干预措施: Physical activity (Behavioral)
Core component+body appreciation+enjoyment of exercise
Participants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive strategies to improve how they think and feel about their bodies, and to explore/identify ways to enjoy physical activity.
干预措施: Body Appreciation (Behavioral)
Core component+body appreciation+enjoyment of exercise
Participants in this condition will receive guidance and support for healthy eating and regular physical activity. They will also receive strategies to improve how they think and feel about their bodies, and to explore/identify ways to enjoy physical activity.
干预措施: Enjoyable Exercise (Behavioral)
结局指标
主要结局
Client Satisfaction Questionnaire
时间窗: End of treatment, 12 weeks
This 8-item self-report measure captures perceived quality and usefulness and overall satisfaction with treatment. Scores range from 8-32 with higher scores reflecting a more positive view of treatment.
次要结局
未报告次要终点