ObesityNCT01777711
Exploring Beliefs and Behaviors About Weight Loss in Couples
A study testing Mental Contrasting- Individual and Mental Contrasting- Couple in people with Obesity, run by Duke University at 1 site in United States.
Trial summary
This study explores among couples in which both members are obese how the use of mental contrasting along with implementation intentions influence intentions and behavior related to weight loss (eating healthy and exercise), actual weight loss, as well as potential reasons (i.e., mediators) why these changes may occur… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Mental Contrasting- Individual and Mental Contrasting- Couple
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Apr 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Married couples or couples living as married
- living in the same household for at least six months
- both members of couple are obese (BMI > 30).
- must be 18 years or older
- can read and write in English
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
This study explores among couples in which both members are obese how the use of mental contrasting along with implementation intentions influence intentions and behavior related to weight loss (eating healthy and exercise), actual weight loss, as well as potential reasons (i.e., mediators) why these changes may occur (e.g., social support, changes in beliefs about weight loss, confidence in being able to eat healthy and diet).
Read the detailed description
This study explores among couples in which both members are obese how the use of mental contrasting along with implementation intentions influence intentions and behaviors related to weight loss (eating healthy and exercise), actual weight loss, as well as potential reasons (i.e., mediators) why these changes may occur (e.g., social support, changes in beliefs about weight loss, confidence in being able to eat healthy and diet). In mental contrasting procedures, people first imagine a desired future (e.g., eating healthy) and then reflect on the current negative reality (e.g., I snack too much). This process makes people aware of changes needed in the present to obtain future positive outcomes, and thus aids in increasing goal commitment and goal pursuit. In implementation intention procedures, individuals form "if-then" statements about how they will enact their goals in their everyday lives. Implementation intentions are highly effective at helping individuals achieve health behavior change. Recent studies suggest that the combined use of mental contrasting and implementation intentions produce more behavior change than either technique alone (e.g., diet) In this study, investigators test whether these procedures vary in their effectiveness when couple members are instructed to focus on themselves versus the relationship, the latter intended to instill a communal coping mindset (i.e., that losing weight is an issue that needs to be addressed as a couple enacted through mutually cooperative behaviors).
- Conditions
- Obesity
- Being tested
- Mental Contrasting- Individual, Mental Contrasting- Couple
- Keywords
- mental contrasting, weight loss, obese couples, obesity, overweight, planning, health, diet, exercise, physical activity, goal, goal-setting
- Medical subject headings
- Obesity, Weight Loss, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Contrasting- IndividualBehavioural
Investigators will implement the manipulation of mental contrasting/implementation intentions, focusing on the individual. This will entail 3 steps that involve: 1) contrasting of positive future outcomes associated with present conditions that hinder achievement of positive future outcomes (i.e., barriers); 2) strategies to overcome barriers and hence facilitate weight loss; and 3) construction of implementation intentions.
Mental Contrasting- CoupleBehavioural
Investigators will implement the manipulation of mental contrasting/implementation intentions, focusing on the couple. This will entail 3 steps that involve: 1) contrasting of positive future outcomes associated with present conditions that hinder achievement of positive future outcomes (i.e., barriers); 2) strategies to overcome barriers and hence facilitate weight loss; and 3) construction of implementation intentions.
| Study group | Role | What they receive |
|---|---|---|
| Couple condition | Active comparator | Couples randomized to the couple condition will undergo the experimental manipulations and both partners will complete all study measures. Both members of the couple will be given body mass index (BMI) based on measurements taken during the intervention. Both will complete three surveys on paper and do some prompted planning and goal-setting together regarding weight loss through healthier eating and physical activity. Receives: Behavioral: Mental Contrasting- Couple |
| Individual Condition | Active comparator | Couples randomized to the individual condition will be stratified on gender and one partner, chosen at random, will undergo the experimental manipulations and complete all study surveys while the other will not (heretofore called the active partner vs. the passive partner). The active partner will receive BMI feedback based on measurements taken during the intervention appointment, complete three surveys, and verbally state some goals and plans for weight loss to the passive partner. The passive partner will not complete any study materials or participate in the intervention during the session. Receives: Behavioral: Mental Contrasting- Individual |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Measure weight loss between baseline and one month visits
Measured: one month
Secondary outcomes (2)
dietary changes
Look at dietary changes in self-report questionnaire.
Measured: one month
number of minutes of physical activity
Measure minutes of physical activity through self-report questionnaire.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionApr 2014
- Study completionApr 2014
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.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isaac Lipkus, PhD, Principal investigator, Duke University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777711
- Sponsor's protocol ID
- Pro00040490
- Status last verified
- Sep 2014
- First submitted
- 25 Jan 2013
- Last updated
- 26 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Beliefs and Behaviors About Weight Loss in Couples
- ClinicalTrials.gov ID
- NCT01777711
- Acronym / sponsor ID
- Pro00040490
- Conditions
- Obesity
- Keywords
- mental contrasting, weight loss, obese couples, obesity, overweight, planning, health, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 29 Jan 2013 (estimated)
- 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.
This study explores among couples in which both members are obese how the use of mental contrasting along with implementation intentions influence intentions and behavior related to weight loss (eating healthy and exercise), actual weight loss, as well as potential reasons (i.e., mediators) why these changes may occur (e.g., social support, changes in beliefs about weight loss, confidence in being able to eat healthy and diet).
Detailed description
This study explores among couples in which both members are obese how the use of mental contrasting along with implementation intentions influence intentions and behaviors related to weight loss (eating healthy and exercise), actual weight loss, as well as potential reasons (i.e., mediators) why these changes may occur (e.g., social support, changes in beliefs about weight loss, confidence in being able to eat healthy and diet). In mental contrasting procedures, people first imagine a desired future (e.g., eating healthy) and then reflect on the current negative reality (e.g., I snack too much). This process makes people aware of changes needed in the present to obtain future positive outcomes, and thus aids in increasing goal commitment and goal pursuit. In implementation intention procedures, individuals form "if-then" statements about how they will enact their goals in their everyday lives. Implementation intentions are highly effective at helping individuals achieve health behavior change. Recent studies suggest that the combined use of mental contrasting and implementation intentions produce more behavior change than either technique alone (e.g., diet) In this study, investigators test whether these procedures vary in their effectiveness when couple members are instructed to focus on themselves versus the relationship, the latter intended to instill a communal coping mindset (i.e., that losing weight is an issue that needs to be addressed as a couple enacted through mutually cooperative behaviors).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Couple condition | Active comparator | Behavioral: Mental Contrasting- CoupleCouples randomized to the couple condition will undergo the experimental manipulations and both partners will complete all study measures. Both members of the couple will be given body mass index (BMI) based on measurements taken during the intervention. Both will complete three surveys on paper and do some prompted planning and goal-setting together regarding weight loss through healthier eating and physical activity. |
| Individual Condition | Active comparator | Behavioral: Mental Contrasting- IndividualCouples randomized to the individual condition will be stratified on gender and one partner, chosen at random, will undergo the experimental manipulations and complete all study surveys while the other will not (heretofore called the active partner vs. the passive partner). The active partner will receive BMI feedback based on measurements taken during the intervention appointment, complete three surveys, and verbally state some goals and plans for weight loss to the passive partner. The passive partner will not complete any study materials or participate in the intervention during the session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Married couples or couples living as married
- living in the same household for at least six months
- both members of couple are obese (BMI > 30).
- must be 18 years or older
- can read and write in English
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Mental Contrasting- IndividualInvestigators will implement the manipulation of mental contrasting/implementation intentions, focusing on the individual. This will entail 3 steps that involve: 1) contrasting of positive future outcomes associated with present conditions that hinder achievement of positive future outcomes (i.e., barriers); 2) strategies to overcome barriers and hence facilitate weight loss; and 3) construction of implementation intentions. | Behavioural | Individual Condition |
| Mental Contrasting- CoupleInvestigators will implement the manipulation of mental contrasting/implementation intentions, focusing on the couple. This will entail 3 steps that involve: 1) contrasting of positive future outcomes associated with present conditions that hinder achievement of positive future outcomes (i.e., barriers); 2) strategies to overcome barriers and hence facilitate weight loss; and 3) construction of implementation intentions. | Behavioural | Couple condition |
Primary outcome
weight loss
Time frame: one month
Measure weight loss between baseline and one month visits
2 secondary outcomes
dietary changes
Time frame: one month
number of minutes of physical activity
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2014.
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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.
Isaac Lipkus, PhD principal investigator
Duke University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Contrasting- Individual and Mental Contrasting- Couple in people with Obesity, run by Duke University at 1 site in United States.
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 5 inclusion and 0 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: finished, as of the sponsor's last update on 26 Sep 2014. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
weight loss (time frame: one month). 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 26 Sep 2014.