- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02898844
Randomized Controlled Experiment of Dieting in Pairs
September 12, 2016 updated by: A. Janet Tomiyama
This study examined how dieting with a partner affects weight loss, diet adherence, psychological well-being, and cortisol.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The goal of this study was to understand how different types of diet "buddy systems" affect diet success and outcomes related to dieting.
Pairs of non-romantic cohabiting female dyads (i.e.
roommates) were randomly assigned to one of the following three-week manipulations: (a) neither roommate dieted, (b) one roommate was assigned to a 1200-calorie/day diet and the other ate normally, (c) both roommates were assigned to a 1200-calorie/day diet.
Both pre- and post diet, participants were weighted and measured, filled out psychological questionnaires, and provided two days of diurnal salivary cortisol samples.
During the three-week manipulation period, participants who were assigned to diet recorded all calories consumed on each day.
This study tested whether dieting in a pair would lead to improved diet outcomes in terms of adherence and weight loss, changes in psychological well-being, and changes in cortisol.
Study Type
Interventional
Enrollment (Actual)
164
Phase
- Not Applicable
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
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female
- Over 18 years of age
- Interested in dieting in the coming 12 months
- self-reported BMI over 18.5
- < 5 kg weight change in previous 3 months
- Have a university meal plan
- Have a roommate also willing/eligible to participate
Exclusion Criteria:
- Recent/current history of major medical disorder
- Pregnancy/lactation
- History of eating disorder
- Use of lipid-lowering medications
- Use of weight-altering/metabolism-altering medications
- Smoking
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: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Condition
Neither roommate dieted.
|
|
|
Experimental: Mixed Diet Condition
Low-calorie diet: One roommate in each pair was randomly assigned to a 1200-calorie/day diet, while the other roommate was instructed to eat normally.
|
One roommate dieted and the other ate normally.
|
|
Experimental: Both Diet Condition
Low-calorie diet: Both roommates in each pair were randomly assigned to a 1200-calorie/day diet.
|
Both roommates dieted.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Psychological well-being measured via electronic questionnaires
Time Frame: ~3 days after end of 3-week manipulation
|
~3 days after end of 3-week manipulation
|
|
Weight loss measured via pounds
Time Frame: ~3 days after end of 3-week manipulation
|
~3 days after end of 3-week manipulation
|
|
Diet adherence measured via daily calorie counts
Time Frame: up to 3-week
|
up to 3-week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cortisol measured via 2 days diurnal cortisol
Time Frame: 1 day after end of 3-week manipulation
|
1 day after end of 3-week manipulation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: A. Janet Tomiyama, PhD, University of California, Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.
- Spielberger CD, Gorsuch RL, Lushene RE. State-trait anxiety inventory (self-evaluation questionnaire). Consulting Psychologists Press: 1970.
- Radloff, L. S. The CES-D scale a self-report depression scale for research in the general population. Applied psychological measurement, 1(3): 385-401, 1977.
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
October 1, 2013
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
September 8, 2016
First Submitted That Met QC Criteria
September 12, 2016
First Posted (Estimate)
September 13, 2016
Study Record Updates
Last Update Posted (Estimate)
September 13, 2016
Last Update Submitted That Met QC Criteria
September 12, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 13-000666
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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