NCT04660968

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Dec 2020

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

December 15, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
Last Updated

February 22, 2023

Status Verified

March 1, 2022

Enrollment Period

2.5 years

First QC Date

October 28, 2020

Last Update Submit

February 21, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • 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 weight (kg)

    Baseline, 4 months, 7 months, 16 months

  • Change in waist circumference (cm)

    Baseline, 4 months, 7 months, 16 months

  • Change in Relationship Satisfaction

    Baseline, 4 months, 7 months, 16 months

  • +5 more secondary outcomes

Other Outcomes (7)

  • Changes in Self-Efficacy for Exercise

    Baseline, 4 months, 7 months, 16 months

  • Changes in Self-Efficacy for Diet

    Baseline, 4 months, 7 months, 16 months

  • Changes in Action Planning

    Baseline, 4 months, 7 months, 16 months

  • +4 more other outcomes

Study Arms (2)

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.

Behavioral: Dyadic health behaviour change intervention

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.

Behavioral: Dyadic nutrition counselling intervention

Interventions

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 Health Behaviour Change 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.

Dyadic nutrition counselling intervention

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Currently enrolled in a weight loss program
  • On a special diet
  • Eating disorder
  • Uncontrolled diabetes
  • Stroke
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Concordia University

Montreal, Quebec, H4B1R6, Canada

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2020

First Posted

December 9, 2020

Study Start

December 15, 2020

Primary Completion

June 15, 2023

Study Completion

November 15, 2024

Last Updated

February 22, 2023

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Anonymized study data available upon request

Locations