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临床试验/NCT05796141
NCT05796141进行中(未招募)不适用

Optimizing a Couples-Based mHealth Intervention for Weight Management

University of Connecticut2 个研究点 分布在 1 个国家目标入组 762 人开始时间: 2024年3月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
762
试验地点
2
主要终点
Body Weight (kg)

研究概览

简要总结

The goal of this project is to investigate how to enhance the effects of an online-only (mHealth) couples weight loss program. This study will use an innovative methodological framework, the Multiphase Optimization Strategy (MOST), to test four different strategies for weight loss and partner support in addition to a core intervention (i.e., dyadic action planning, joint feedback on goal progress, autonomy support training, and home environment modifications).

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
Single (Outcomes Assessor)

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

入选标准

  • Married/cohabitating couple - both partners must be eligible
  • BMI between 25-55kg/m2
  • English speaking/reading
  • Have a smartphone and reliable internet access
  • Have active email address
  • Willing to videoconference

排除标准

  • Report being unable to walk 2 blocks without stopping
  • Are currently participating in weight loss treatment, have a history of bariatric surgery, or lost ≥5% in the past 6-months
  • Are pregnant or plan to become pregnant during the study period
  • Report chest pain or loss of consciousness on the Physical Activity Readiness Questionnaire
  • Report a medical condition that could jeopardize their safety in a weight control program with diet and exercise guidelines
  • Report conditions that, in the judgment of the PI, would render them unlikely to follow the protocol (e.g. dementia)

研究组 & 干预措施

Condition 11

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Autonomy Support Training

干预措施: Dyadic Action Planning (Behavioral)

Condition 4

Experimental

1) Core BWL Intervention; 2) Autonomy Support Training; 3) Home Environment Modifications

干预措施: Home Environment Modifications (Behavioral)

Condition 1

Experimental

1) Core BWL Intervention

干预措施: Core Behavioral Weight Loss (BWL) intervention (Behavioral)

Condition 2

Experimental

1) Core BWL Intervention; 2) Home Environment Modifications

干预措施: Core Behavioral Weight Loss (BWL) intervention (Behavioral)

Condition 2

Experimental

1) Core BWL Intervention; 2) Home Environment Modifications

干预措施: Home Environment Modifications (Behavioral)

Condition 3

Experimental

1) Core BWL Intervention; 2) Autonomy Support Training

干预措施: Core Behavioral Weight Loss (BWL) intervention (Behavioral)

Condition 3

Experimental

1) Core BWL Intervention; 2) Autonomy Support Training

干预措施: Autonomy Support Training (Behavioral)

Condition 4

Experimental

1) Core BWL Intervention; 2) Autonomy Support Training; 3) Home Environment Modifications

干预措施: Core Behavioral Weight Loss (BWL) intervention (Behavioral)

Condition 4

Experimental

1) Core BWL Intervention; 2) Autonomy Support Training; 3) Home Environment Modifications

干预措施: Autonomy Support Training (Behavioral)

Condition 5

Experimental

1) Core BWL Intervention; 2) Joint Feedback

干预措施: Core Behavioral Weight Loss (BWL) intervention (Behavioral)

Condition 5

Experimental

1) Core BWL Intervention; 2) Joint Feedback

干预措施: Joint Feedback (Behavioral)

Condition 6

Experimental

1) Core BWL Intervention; 2) Joint Feedback; 3) Home Environment Modifications

干预措施: Core Behavioral Weight Loss (BWL) intervention (Behavioral)

Condition 6

Experimental

1) Core BWL Intervention; 2) Joint Feedback; 3) Home Environment Modifications

干预措施: Joint Feedback (Behavioral)

Condition 6

Experimental

1) Core BWL Intervention; 2) Joint Feedback; 3) Home Environment Modifications

干预措施: Home Environment Modifications (Behavioral)

Condition 7

Experimental

1) Core BWL Intervention; 2) Joint Feedback; 3) Autonomy Support Training

干预措施: Core Behavioral Weight Loss (BWL) intervention (Behavioral)

Condition 7

Experimental

1) Core BWL Intervention; 2) Joint Feedback; 3) Autonomy Support Training

干预措施: Joint Feedback (Behavioral)

Condition 7

Experimental

1) Core BWL Intervention; 2) Joint Feedback; 3) Autonomy Support Training

干预措施: Autonomy Support Training (Behavioral)

Condition 8

Experimental

1) Core BWL Intervention; 2) Joint Feedback; 3) Autonomy Support Training; 4) Home Environment Modifications

干预措施: Core Behavioral Weight Loss (BWL) intervention (Behavioral)

Condition 8

Experimental

1) Core BWL Intervention; 2) Joint Feedback; 3) Autonomy Support Training; 4) Home Environment Modifications

干预措施: Joint Feedback (Behavioral)

Condition 8

Experimental

1) Core BWL Intervention; 2) Joint Feedback; 3) Autonomy Support Training; 4) Home Environment Modifications

干预措施: Autonomy Support Training (Behavioral)

Condition 8

Experimental

1) Core BWL Intervention; 2) Joint Feedback; 3) Autonomy Support Training; 4) Home Environment Modifications

干预措施: Home Environment Modifications (Behavioral)

Condition 9

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning

干预措施: Core Behavioral Weight Loss (BWL) intervention (Behavioral)

Condition 9

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning

干预措施: Dyadic Action Planning (Behavioral)

Condition 10

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Home Environment Modifications

干预措施: Core Behavioral Weight Loss (BWL) intervention (Behavioral)

Condition 10

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Home Environment Modifications

干预措施: Dyadic Action Planning (Behavioral)

Condition 10

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Home Environment Modifications

干预措施: Home Environment Modifications (Behavioral)

Condition 11

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Autonomy Support Training

干预措施: Core Behavioral Weight Loss (BWL) intervention (Behavioral)

Condition 11

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Autonomy Support Training

干预措施: Autonomy Support Training (Behavioral)

Condition 12

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Autonomy Support Training 4) Home Environment Modifications

干预措施: Core Behavioral Weight Loss (BWL) intervention (Behavioral)

Condition 12

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Autonomy Support Training 4) Home Environment Modifications

干预措施: Dyadic Action Planning (Behavioral)

Condition 12

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Autonomy Support Training 4) Home Environment Modifications

干预措施: Autonomy Support Training (Behavioral)

Condition 12

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Autonomy Support Training 4) Home Environment Modifications

干预措施: Home Environment Modifications (Behavioral)

Condition 13

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback

干预措施: Core Behavioral Weight Loss (BWL) intervention (Behavioral)

Condition 13

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback

干预措施: Dyadic Action Planning (Behavioral)

Condition 13

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback

干预措施: Joint Feedback (Behavioral)

Condition 14

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback; 4) Home Environment Modifications

干预措施: Core Behavioral Weight Loss (BWL) intervention (Behavioral)

Condition 14

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback; 4) Home Environment Modifications

干预措施: Dyadic Action Planning (Behavioral)

Condition 14

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback; 4) Home Environment Modifications

干预措施: Joint Feedback (Behavioral)

Condition 14

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback; 4) Home Environment Modifications

干预措施: Home Environment Modifications (Behavioral)

Condition 15

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback; 4) Autonomy Support Training

干预措施: Core Behavioral Weight Loss (BWL) intervention (Behavioral)

Condition 15

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback; 4) Autonomy Support Training

干预措施: Dyadic Action Planning (Behavioral)

Condition 15

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback; 4) Autonomy Support Training

干预措施: Joint Feedback (Behavioral)

Condition 15

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback; 4) Autonomy Support Training

干预措施: Autonomy Support Training (Behavioral)

Condition 16

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback; 4) Autonomy Support Training; 5) Home Environment Modifications

干预措施: Core Behavioral Weight Loss (BWL) intervention (Behavioral)

Condition 16

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback; 4) Autonomy Support Training; 5) Home Environment Modifications

干预措施: Dyadic Action Planning (Behavioral)

Condition 16

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback; 4) Autonomy Support Training; 5) Home Environment Modifications

干预措施: Joint Feedback (Behavioral)

Condition 16

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback; 4) Autonomy Support Training; 5) Home Environment Modifications

干预措施: Autonomy Support Training (Behavioral)

Condition 16

Experimental

1) Core BWL Intervention; 2) Dyadic Action Planning; 3) Joint Feedback; 4) Autonomy Support Training; 5) Home Environment Modifications

干预措施: Home Environment Modifications (Behavioral)

结局指标

主要结局

Body Weight (kg)

时间窗: Baseline to 6 months

Weight change from baseline to 6 months. Weight will be objectively measured on a digital scale in the participant's home and weight change will be calculated.

次要结局

  • Transactive Density(Baseline, 3 months, 6 months)
  • Physical Activity (Paffenbarger Physical Activity Questionnaire)(Baseline, 3 months, 6 months)
  • Home Food Environment (Household Food Inventory)(Baseline, 3 months, 6 months)
  • Dietary Intake(Baseline, 3 months, 6 months)
  • Goal Coordination (Wingrove Goal Coordination Scale)(Baseline, 3 months, 6 months)
  • Shared Goal Representation(Baseline, 3 months, 6 months)
  • Home Exercise Environment (Exercise Environment Questionnaire)(Baseline, 3 months, 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amy Gorin

Vice Provost for Health Sciences and Interdisciplinary Initiatives

University of Connecticut

研究点 (2)

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