Clinical trial NCT04660968: Dyadic Approach To Active Living and Eating Healthy: The DATE Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: Concordia University, Montreal
Sponsor class: OTHER
Collaborators: name: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
First posted: 2020-12-09
Enrollment: 70
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Currently enrolled in a weight loss program
2. On a special diet
3. Eating disorder
4. Uncontrolled diabetes
5. Stroke
6. Heart problems (heart attack, heart failure, surgery of the heart or of the carotid arteries, pacemaker)
7. Other medical issues or medical treatment that would prevent doing physical activity

Primary outcomes:
measure: Change in Healthy Eating Index
timeFrame: Baseline, 4 months, 7 months, 16 months
Secondary outcomes:
measure: Change in Moderate-to-Vigorous Physical Activity (minutes per day)
timeFrame: Baseline, 4 months, 7 months, 16 months
measure: Change in self-reported physical Activity
timeFrame: Baseline, 4 months, 7 months, 16 months
measure: Change in weight (kg)
timeFrame: Baseline, 4 months, 7 months, 16 months
measure: Change in waist circumference (cm)
timeFrame: Baseline, 4 months, 7 months, 16 months
measure: Change in Relationship Satisfaction
timeFrame: Baseline, 4 months, 7 months, 16 months
measure: Change in Dyadic Coping
timeFrame: Baseline, 4 months, 7 months, 16 months
measure: Change in Spousal Social Support for Diet
timeFrame: Baseline, 4 months, 7 months, 16 months
measure: Change in Spousal Social Support for Exercise
timeFrame: Baseline, 4 months, 7 months, 16 months
measure: Change in Communal Coping
timeFrame: Baseline, 4 months, 7 months, 16 months
measure: Change in Autonomy Support
timeFrame: Baseline, 4 months, 7 months, 16 months
Other outcomes:
measure: Changes in Self-Efficacy for Exercise
timeFrame: Baseline, 4 months, 7 months, 16 months
measure: Changes in Self-Efficacy for Diet
timeFrame: Baseline, 4 months, 7 months, 16 months
measure: Changes in Action Planning
timeFrame: Baseline, 4 months, 7 months, 16 months
measure: Changes in Functional Fitness
timeFrame: Baseline, 4 months, 7 months, 16 months
measure: Changes in Maximal Handgrip Strength (kg)
timeFrame: Baseline, 4 months, 7 months, 16 months
measure: Changes in Depressive Symptoms
timeFrame: Baseline, 4 months, 7 months, 16 months
measure: Changes in Sleep Quality
timeFrame: Baseline, 4 months, 7 months, 16 months
Locations:
city: Montréal
country: Canada
facility: Concordia University
state: Quebec
Study officials:
References: