Dyadic Approach To Active Living and Eating Healthy: The DATE Study

Obesity Clinical Trial

— DATE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04660968
• Other study ID #: 30011381
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: November 15, 2024

Study information

• Verified date: March 2022
• Source: Concordia University, Montreal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: November 15, 2024
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Dyadic health behaviour change intervention
The dyadic behaviour change intervention adopts a dyadic coping perspective wherein appraisal of shared responsibility, agreement on tasks, and collaboration are fostered throughout the intervention. The intervention will target four behaviour goals: reducing overall caloric intake, substituting empty calorie foods with healthier alternatives, reducing sedentary behaviour, and increasing physical activity. The specific behavioural change strategies will include motivational interviewing, self-monitoring, goal setting, stimulus control, problem solving, and relapse prevention. Each session will also include a short education component on healthy eating to improve participants' adherence to the updated Canada's Food Guide. Participants will have access to web-based exercise training sessions. Intervention sessions will be delivered online.
• Dyadic nutrition counselling intervention
The couples-based education nutrition intervention will provide extensive information on healthy eating. However, it will not include any behavioural change principles. Topics will be based on Dietitians of Canada's Practice-based Evidence in Nutrition (PEN) discussions in the database that focus on healthy eating for older adults. The topics covered will include increasing fruits and vegetables, hidden (empty) calories, how to read food labels, portion control, reducing salt and saturated fat, plant-based proteins, and eating for healthy bones. Participants in this group will also be told to increase their levels of physical activity to 150 minutes of moderate to vigorous physical activity per week, as per the Canadian Guidelines. Participants will have access to web-based exercise training sessions. However, physical activity will not be discussed explicitly during the intervention. Intervention sessions will be delivered online.

Locations

Country	Name	City	State
Canada	Concordia University	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Concordia University, Montreal	Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Self-Efficacy for Exercise	Self-Efficacy for Exercise assessed using the Self-Efficacy for Exercise Scale (total score ranges from 5-25, with higher score indicating greater exercise self-efficacy).	Baseline, 4 months, 7 months, 16 months
Other	Changes in Self-Efficacy for Diet	Self-Efficacy for Diet assessed using the Weight Efficacy LifeStyle Questionnaire (total score ranges from 0-180, with higher score indicating greater diet self-efficacy).	Baseline, 4 months, 7 months, 16 months
Other	Changes in Action Planning	Action planning assessed using a home-made questionnaire based on the Health Action Process Approach (total score ranges from 0-54, with greater score indicating more action planning).	Baseline, 4 months, 7 months, 16 months
Other	Changes in Functional Fitness	Functional fitness assessed using the Short Physical Performance Battery (total score ranges from 0-12 with higher score indicating better functional fitness).	Baseline, 4 months, 7 months, 16 months
Other	Changes in Maximal Handgrip Strength (kg)	Maximal handgrip strength assessed using a hand dynamometer.	Baseline, 4 months, 7 months, 16 months
Other	Changes in Depressive Symptoms	Depressive symptoms assessed using the Center for Epidemiological Study-Depression (total score ranges 0 to 60, with higher score indicating more depressive symptoms)	Baseline, 4 months, 7 months, 16 months
Other	Changes in Sleep Quality	Sleep quality assessed using Pittsburgh Sleep Quality Index (total score ranges 0 to 21, with higher score indicating poorer sleep quality)	Baseline, 4 months, 7 months, 16 months
Primary	Change in Healthy Eating Index	Canadian adaptation of the Healthy Eating Index based on a 3-day food diary	Baseline, 4 months, 7 months, 16 months
Secondary	Change in Moderate-to-Vigorous Physical Activity (minutes per day)	Objective physical activity assessed using accelerometry for 7 consecutive days.	Baseline, 4 months, 7 months, 16 months
Secondary	Change in self-reported physical Activity	Self-reported physical activity assessed using the Physical Activity Scale for the Elderly (total score ranges from 0 to 793, with higher scores indicating greater physical activity).	Baseline, 4 months, 7 months, 16 months
Secondary	Change in weight (kg)	Body weight assessed using a digital scale	Baseline, 4 months, 7 months, 16 months
Secondary	Change in waist circumference (cm)	Waist circumference assessed using a measuring tape anchored at the top of the hip bone.	Baseline, 4 months, 7 months, 16 months
Secondary	Change in Relationship Satisfaction	Relationship satisfaction assessed using the Couples Satisfaction Index-4 (total score ranges from 0-21, with higher scores indicating greater relationship satisfaction).	Baseline, 4 months, 7 months, 16 months
Secondary	Change in Dyadic Coping	Dyadic coping assessed using the Common Dyadic Coping subscale of the Dyadic Coping Inventory (total score ranges from 0-30, with higher scores indicating common more dyadic coping).	Baseline, 4 months, 7 months, 16 months
Secondary	Change in Spousal Social Support for Diet	Diet social support assessed using the spousal version of the Social Support for Diet (total score ranges from 0 to 50 with higher scores indicating greater social support for diet).	Baseline, 4 months, 7 months, 16 months
Secondary	Change in Spousal Social Support for Exercise	Spousal social support for exercise assessed using the spousal version of the Social Support for Exercise scale (total score ranges from 0 to 60 with higher scores indicating greater social support for exercise).	Baseline, 4 months, 7 months, 16 months
Secondary	Change in Communal Coping	Communal coping assessed using a home-made communal coping scale (total score range from 6-60 with higher score indicating greater communal coping).	Baseline, 4 months, 7 months, 16 months
Secondary	Change in Autonomy Support	Autonomy support assessed using the spousal version for the Important Other Climate Questionnaire (total scores 6-42, with higher scores indicating more autonomy support).	Baseline, 4 months, 7 months, 16 months