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临床试验/NCT04660968
NCT04660968进行中(未招募)不适用

Dyadic Approach To Active Living and Eating Healthy: a Randomized Controlled Trial of a Dyadic Health Behavior Change Intervention vs. Nutrition Education for Older Adult Obese Couples

Concordia University, Montreal1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年12月15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)
发起方
入组人数
70
试验地点
1
主要终点
Change in Healthy Eating Index

研究概览

简要总结

The purpose of the DATE study is to evaluate the feasibility and acceptability and a preliminary evaluation of the efficacy of a dyadic health behaviour change intervention to improve healthy eating, physical activity, and dyadic coping among older obese couples. This novel intervention will use a dyadic adaptation of common health behaviour change strategies and will promote a dyadic coping approach to health behaviour change that emphasize partners' interdependence and shared responsibility for the creation of a home environment conducive to a healthy lifestyle. For this project 35 obese older adults cohabiting dyads will be randomized to either the couples-based dyadic health behaviour change intervention or a couples-based nutrition counselling control condition.

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)

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
是

入选标准

  • •At least one of the partners is retired
  • •Partners cohabitating for at least 2 years.
  • •Obesity: BMI between 30-45 kg/m2

排除标准

  • •Currently enrolled in a weight loss program
  • •On a special diet
  • •Eating disorder
  • •Uncontrolled diabetes
  • •Heart problems (heart attack, heart failure, surgery of the heart or of the carotid arteries, pacemaker)
  • •Other medical issues or medical treatment that would prevent doing physical activity

研究组 & 干预措施

Dyadic Health Behaviour Change Intervention

Experimental

The dyadic health behaviour change intervention is a 10 sessions program provided over 16 weeks. It includes nutritional, physical activity and sedentary related information, as well as couples-based adaptation of motivational interviewing, self-monitoring, goals setting, stimulus control, problem-solving, and relapse prevention as well as specific strategies to support their partner's autonomy and intrinsic motivation.

干预措施: Dyadic health behaviour change intervention (Behavioral)

Dyadic nutrition counselling intervention

Active Comparator

The couples-based nutrition counselling intervention is a 10 sessions program provided over 16 weeks. Topics are based on Dietitians of Canada's Practice-based Evidence in Nutrition discussions. Participants are also encouraged to meet the current physical activity recommendations. Both members of the couples are seen at the same, but no intervention target specifically the behaviour change process or the romantic relationship.

干预措施: Dyadic nutrition counselling intervention (Behavioral)

结局指标

主要结局

Change in Healthy Eating Index

时间窗: Baseline, 4 months, 7 months, 16 months

Canadian adaptation of the Healthy Eating Index based on a 3-day food diary

次要结局

  • Change in Communal Coping(Baseline, 4 months, 7 months, 16 months)
  • Change in Moderate-to-Vigorous Physical Activity (minutes per day)(Baseline, 4 months, 7 months, 16 months)
  • Change in self-reported physical Activity(Baseline, 4 months, 7 months, 16 months)
  • Change in Relationship Satisfaction(Baseline, 4 months, 7 months, 16 months)
  • Change in Dyadic Coping(Baseline, 4 months, 7 months, 16 months)
  • Change in Spousal Social Support for Diet(Baseline, 4 months, 7 months, 16 months)
  • Change in weight (kg)(Baseline, 4 months, 7 months, 16 months)
  • Change in waist circumference (cm)(Baseline, 4 months, 7 months, 16 months)
  • Change in Spousal Social Support for Exercise(Baseline, 4 months, 7 months, 16 months)
  • Change in Autonomy Support(Baseline, 4 months, 7 months, 16 months)

研究者

发起方
Concordia University, Montreal
申办方类型
Other
责任方
Sponsor

研究点 (1)

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