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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Dyadic health behaviour change intervention; Behavioral: Dyadic nutrition counselling intervention

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H4B1R6
      • Concordia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dyadic Health Behaviour Change Intervention; 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.	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.
Active Comparator: Dyadic nutrition counselling intervention; 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Change in weight (kg)	Body weight assessed using a digital scale	Baseline, 4 months, 7 months, 16 months
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
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Changes in Maximal Handgrip Strength (kg)	Maximal handgrip strength assessed using a hand dynamometer.	Baseline, 4 months, 7 months, 16 months
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
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

Collaborators and Investigators

• Sponsor: Concordia University, Montreal
• Collaborators: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Anticipated): June 15, 2023
• Study Completion (Anticipated): November 15, 2024

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 30011381

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Anonymized study data available upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No