Clinical trial NCT03163082: Couple Interaction and Health Behaviors
Official title: Targeting Couple Coercion to Impact Health Behaviors and Regimen Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Couples
Relationship, Marital
Keywords: Coercion theory
Corrosive Couple Coercion
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2017-05-22
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Within-subject design over 2 visits.
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators are interested in typical couple interactions and health behaviors. In particular, the investigators are interested in different ways that each partner in a coupled relationship reacts to and understand each other's behavior, and in their health behaviors.

Detailed description: If couples decide to participate in this study, they will come visit the laboratory at a time that is convenient for them.

Couples will be asked to participate in the following activities. These activities will be video recorded and recordings will be kept digitally on a secure password-protected server. Video recordings will be assigned a number, and names and identifying information will not be associated in any way with the video recordings. If couples do not want to be video recorded, they can not participate in this research.

* Upon arrival at the laboratory during both visits, the subject runners will explain the tasks to participants. The subject runners also will measure participants' heart rates and skin moisture. To do so the subject runners will place 9 sensors on each person's body: on the collar bones, the lower left rib cage, the upper and mid-chest, the upper and mid-back, and the palm of their nondominant hand. The sensors will be connected to small machines that participants will carry. Participants will still be able to move freely around the room.
* Partners will be asked to sit separately while they complete a questionnaire that asks about their relationship.
* There will either be:

  * A short discussion where the subject runners will discuss their responses to their partner's behavior or the intentions behind their partner's behavior. A quarter of the research subjects in this study will complete a task where their responses to their partner's behaviors are discussed and another quarter of the subjects will complete a task where the reasons for their partner's behavior are discussed. Which type of discussion they have will be "randomly assigned", which means that a computer will generate this decision before they arrive for their visit.
  * Or a short computerized activity where partners will look at a series of images and descriptions or will be asked to rate a series of images with facial expressions. A quarter of the research subjects in this study will complete a computerized activity where they will look at a series of images and descriptions and another quarter of the subjects will complete a computerized activity where they will rate a series of images with facial expressions. Which type of activity participants have will be "randomly assigned", which means that a computer will generate this decision before they arrive for their visit.
* Couples will complete a video-recorded problem-solving task, where they discuss some of the things that they would like each other to do, do different, or change.
* There will either be:

  * A 10-minute break. Drinks and snacks will be provided during the break.
  * Or a task where partners will rate what they felt and thought during their conversation with their partner while watching a video of their conversation.
* At the end of these activities, the subject runners will provide couples with the opportunity to discuss the visit and any other questions or concerns they may have. They will not be asked to participate in any additional visits or questionnaires after their second visit.

Eligibility criteria: Inclusion Criteria:

* Both partners must be 18 years of age or older
* At least one of the partners in the couple dyad carries a Type 2 Diabetes (T2D) diagnosis or is at risk for T2D.
* The couple must qualify on relationship characteristics
* The couple must be married or have lived together for at least 6 months

Exclusion Criteria:

-If individuals do not meet the above criteria, they will be excluded from the study.

Primary outcomes:
measure: Problem-Solving Task
timeFrame: 20 minutes per visit
measure: Health Behaviors
timeFrame: 10 minutes per visit
measure: Video-Mediated Emotion Recall
timeFrame: 20 Minutes per visit
Secondary outcomes:
measure: Psychophysiological Measures
timeFrame: 1.5-3 hours per visit
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Richard Heyman
role: PRINCIPAL_INVESTIGATOR
References: