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

February 21, 2023 updated by: Concordia University, Montreal

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Healthy Eating Index
Time Frame: Baseline, 4 months, 7 months, 16 months
Canadian adaptation of the Healthy Eating Index based on a 3-day food diary
Baseline, 4 months, 7 months, 16 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Moderate-to-Vigorous Physical Activity (minutes per day)
Time Frame: Baseline, 4 months, 7 months, 16 months
Objective physical activity assessed using accelerometry for 7 consecutive days.
Baseline, 4 months, 7 months, 16 months
Change in self-reported physical Activity
Time Frame: Baseline, 4 months, 7 months, 16 months
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)
Time Frame: Baseline, 4 months, 7 months, 16 months
Body weight assessed using a digital scale
Baseline, 4 months, 7 months, 16 months
Change in waist circumference (cm)
Time Frame: Baseline, 4 months, 7 months, 16 months
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
Time Frame: Baseline, 4 months, 7 months, 16 months
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
Time Frame: Baseline, 4 months, 7 months, 16 months
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
Time Frame: Baseline, 4 months, 7 months, 16 months
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
Time Frame: Baseline, 4 months, 7 months, 16 months
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
Time Frame: Baseline, 4 months, 7 months, 16 months
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
Time Frame: Baseline, 4 months, 7 months, 16 months
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Self-Efficacy for Exercise
Time Frame: Baseline, 4 months, 7 months, 16 months
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
Time Frame: Baseline, 4 months, 7 months, 16 months
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
Time Frame: Baseline, 4 months, 7 months, 16 months
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
Time Frame: Baseline, 4 months, 7 months, 16 months
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)
Time Frame: Baseline, 4 months, 7 months, 16 months
Maximal handgrip strength assessed using a hand dynamometer.
Baseline, 4 months, 7 months, 16 months
Changes in Depressive Symptoms
Time Frame: Baseline, 4 months, 7 months, 16 months
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
Time Frame: Baseline, 4 months, 7 months, 16 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Concordia University, Montreal

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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