Dietary ModificationNCT02898844
Randomized Controlled Experiment of Dieting in Pairs
A study testing Mixed Diet Condition and Both Diet Condition in people with Dietary Modification, run by A. Janet Tomiyama.
Trial summary
This study examined how dieting with a partner affects weight loss, diet adherence, psychological well-being, and cortisol. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification
- What is being tested?
- Mixed Diet Condition and Both Diet Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Dec 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
This study examined how dieting with a partner affects weight loss, diet adherence, psychological well-being, and cortisol.
Read the 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.
- Conditions
- Dietary Modification
- Being tested
- Mixed Diet Condition, Both Diet Condition
- Keywords
- dieting, dyads, psychological well-being, weight loss, cortisol
- Medical subject headings
- Psychological Well-Being, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed Diet ConditionBehavioural
One roommate dieted and the other ate normally.
Both Diet ConditionBehavioural
Both roommates dieted.
| Study group | Role | What they receive |
|---|---|---|
| Control Condition | No intervention | Neither roommate dieted. |
| Mixed Diet Condition | Experimental | 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. Receives: Behavioral: Mixed Diet Condition |
| Both Diet Condition | Experimental | Low-calorie diet: Both roommates in each pair were randomly assigned to a 1200-calorie/day diet. Receives: Behavioral: Both Diet Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological well-being measured via electronic questionnaires
Measured: ~3 days after end of 3-week manipulation
Weight loss measured via pounds
Measured: ~3 days after end of 3-week manipulation
Diet adherence measured via daily calorie counts
Measured: up to 3-week
Secondary outcomes (1)
Cortisol measured via 2 days diurnal cortisol
Measured: 1 day after end of 3-week manipulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dietary ModificationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- A. Janet Tomiyama
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, A. Janet Tomiyama, University of California, Los Angeles
- Investigators
- A. Janet Tomiyama, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898844
- Sponsor's protocol ID
- 13-000666
- Status last verified
- Sep 2016
- First submitted
- 8 Sep 2016
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.
PubMed 7866415Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Experiment of Dieting in Pairs
- ClinicalTrials.gov ID
- NCT02898844
- Acronym / sponsor ID
- 13-000666
- Conditions
- Dietary Modification
- Keywords
- dieting, dyads, psychological well-being, weight loss, cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- A. Janet TomiyamaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Sep 2016 (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 examined how dieting with a partner affects weight loss, diet adherence, psychological well-being, and cortisol.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Condition | No intervention | –Neither roommate dieted. |
| Mixed Diet Condition | Experimental | Behavioral: Mixed Diet ConditionLow-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. |
| Both Diet Condition | Experimental | Behavioral: Both Diet ConditionLow-calorie diet: Both roommates in each pair were randomly assigned to a 1200-calorie/day diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Mixed Diet ConditionOne roommate dieted and the other ate normally. | Behavioural | Mixed Diet Condition |
| Both Diet ConditionBoth roommates dieted. | Behavioural | Both Diet Condition |
Primary outcome
Psychological well-being measured via electronic questionnaires
Time frame: ~3 days after end of 3-week manipulation
Weight loss measured via pounds
Time frame: ~3 days after end of 3-week manipulation
Diet adherence measured via daily calorie counts
Time frame: up to 3-week
1 secondary outcome
Cortisol measured via 2 days diurnal cortisol
Time frame: 1 day after end of 3-week manipulation
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 13 Sep 2016.
- BackgroundSpielberger CD, Gorsuch RL, Lushene RE. State-trait anxiety inventory (self-evaluation questionnaire). Consulting Psychologists Press: 1970.
- BackgroundRadloff, 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.
- Background: PubMed 7866415Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
A. Janet Tomiyama, PhD principal investigator
University of California, Los Angeles
Questions about this trial
What is this clinical trial studying?
A study testing Mixed Diet Condition and Both Diet Condition in people with Dietary Modification, run by A. Janet Tomiyama.
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 7 inclusion and 6 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 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Psychological well-being measured via electronic questionnaires (time frame: ~3 days after end of 3-week manipulation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02898844, which also lists 4 linked publications.
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 13 Sep 2016.