ObesityDATENCT04660968
Dyadic Approach To Active Living and Eating Healthy: The DATE Study
A study testing Dyadic health behaviour change intervention and Dyadic nutrition counselling intervention in people with Obesity, run by Concordia University, Montreal at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Dyadic health behaviour change intervention and Dyadic nutrition counselling intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 15 Dec 2020to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least one of the partners is retired
- Partners cohabitating for at least 2 years.
- Obesity: BMI between 30-45 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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.
- Conditions
- Obesity
- Being tested
- Dyadic health behaviour change intervention, Dyadic nutrition counselling intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyadic health behaviour change interventionBehavioural
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 interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Dyadic nutrition counselling intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Healthy Eating Index
Canadian adaptation of the Healthy Eating Index based on a 3-day food diary
Measured: Baseline, 4 months, 7 months, 16 months
Secondary outcomes (10)
Change in Moderate-to-Vigorous Physical Activity (minutes per day)
Objective physical activity assessed using accelerometry for 7 consecutive days.
Measured: 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).
Measured: Baseline, 4 months, 7 months, 16 months
Change in weight (kg)
Body weight assessed using a digital scale
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline, 4 months, 7 months, 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start15 Dec 2020
- Primary completion15 Jun 2023 (estimated)
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Concordia University, Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660968
- Sponsor's protocol ID
- 30011381
- Acronym
- DATE
- Status last verified
- Mar 2022
- First submitted
- 28 Oct 2020
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized study data available upon request
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04660968
- Acronym / sponsor ID
- DATE / 30011381
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Concordia University, MontrealUniversity, hospital or other
- Collaborators
- Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 15 Jun 2023 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dyadic Health Behaviour Change Intervention | Experimental | Behavioral: Dyadic health behaviour change interventionThe 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. |
| Dyadic nutrition counselling intervention | Active comparator | Behavioral: Dyadic nutrition counselling interventionThe 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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least one of the partners is retired
- Partners cohabitating for at least 2 years.
- Obesity: BMI between 30-45 kg/m2
Key exclusion criteria (7 listed)
- Currently enrolled in a weight loss program
- On a special diet
- Eating disorder
- Uncontrolled diabetes
- Stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dyadic health behaviour change interventionThe 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. | Behavioural | Dyadic Health Behaviour Change Intervention |
| Dyadic nutrition counselling interventionThe 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. | Behavioural | Dyadic nutrition counselling intervention |
Primary outcome
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
10 secondary outcomes
Change in Moderate-to-Vigorous Physical Activity (minutes per day)
Time frame: Baseline, 4 months, 7 months, 16 months
Change in self-reported physical Activity
Time frame: Baseline, 4 months, 7 months, 16 months
Change in weight (kg)
Time frame: Baseline, 4 months, 7 months, 16 months
Change in waist circumference (cm)
Time frame: Baseline, 4 months, 7 months, 16 months
Change in Relationship Satisfaction
Time frame: Baseline, 4 months, 7 months, 16 months
Change in Dyadic Coping
Time frame: Baseline, 4 months, 7 months, 16 months
Change in Spousal Social Support for Diet
Time frame: Baseline, 4 months, 7 months, 16 months
Change in Spousal Social Support for Exercise
Time frame: Baseline, 4 months, 7 months, 16 months
Change in Communal Coping
Time frame: Baseline, 4 months, 7 months, 16 months
Change in Autonomy Support
Time frame: Baseline, 4 months, 7 months, 16 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Individual participant dataSharing planned: No. Anonymized study data available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dyadic health behaviour change intervention and Dyadic nutrition counselling intervention in people with Obesity, run by Concordia University, Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Healthy Eating Index (time frame: Baseline, 4 months, 7 months, 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.