NCT01777711

Brief 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 (e.g., social support, changes in beliefs about weight loss, confidence in being able to eat healthy and diet).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

September 26, 2014

Status Verified

September 1, 2014

Enrollment Period

1.5 years

First QC Date

January 25, 2013

Last Update Submit

September 25, 2014

Conditions

Obesity

Keywords

mental contrastingweight lossobese couplesobesityoverweightplanninghealthdietexercisephysical activitygoalgoal-setting

Outcome Measures

Primary Outcomes (1)

  • weight loss

    Measure weight loss between baseline and one month visits

    one month

Secondary Outcomes (2)

  • dietary changes

    one month

  • number of minutes of physical activity

    one month

Study Arms (2)

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.

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.

Behavioral: Mental Contrasting- Individual

Interventions

Mental Contrasting- IndividualBEHAVIORAL

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.

Individual Condition
Mental Contrasting- CoupleBEHAVIORAL

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.

Couple condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

ObesityWeight LossOverweightMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBehavior

Study Officials

  • Isaac Lipkus, PhD

    Duke University School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2013

First Posted

January 29, 2013

Study Start

October 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

September 26, 2014

Record last verified: 2014-09

Locations

US(1)