Overweight or ObeseNCT02787902
Weight Management in Mothers and Adult Daughters
A study testing Communication and Standard in people with Overweight or Obese, run by University of California, San Diego at 1 site in United States.
Trial summary
The purpose of this study is to develop, implement, and evaluate a behavioral weight management intervention with a communication training component for Mexican-American women. The study has three specific aims. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight or Obese
- What is being tested?
- Communication and Standard
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 31 Dec 2020
- 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Body mass index of 25-50 kg/m2
- Mexican or Mexican-American
Who cannot join
- Pregnancy or plans to become pregnant in the next year
- 5% weight loss in the last 3 months
- History of bariatric surgery
- Serious medical condition or psychological disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
La Jolla, California, 93093
About this study
Official title: Improving Communication and Collaboration for Weight Management in Mother-daughter
The purpose of this study is to develop, implement, and evaluate a behavioral weight management intervention with a communication training component for Mexican-American women. The study has three specific aims.
Aim 1: Develop a behavioral weight loss intervention that modifies evidence-based behavioral weight loss treatment using results from formative data collected from Mexican-American mother-daughter dyads. The adapted intervention will focus on improving dyadic communication and collaboration for providing reciprocal support for healthy eating and physical activity behaviors.
Read more
Aim 2: Implement and evaluate a pilot weight management program adapted for mother-daughter dyads. Dyads will be randomly assigned to partner-based treatment with or without communication skills training.
Aim 3: Evaluate associations between changes in weight, weight-related behaviors, and psychosocial variables with changes in measures assessing interpersonal communication.
- Conditions
- Overweight or Obese
- Being tested
- Communication, Standard
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CommunicationBehavioural
Behavioral weight management program adapted for mother-daughter dyads with communication skills training
StandardBehavioural
Behavioral weight management program adapted for mother-daughter dyads without communication skills training
| Study group | Role | What they receive |
|---|---|---|
| Communication | Experimental | Behavioral weight loss program with communication skills training Receives: Behavioral: Communication |
| Standard | Active comparator | Standard behavioral weight loss program Receives: Behavioral: Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Change in weight from baseline to post-intervention (16 weeks).
Measured: 16 weeks
Secondary outcomes (9)
Anthropometrics
Measured: baseline and post-intervention (16 weeks)
Blood pressure
Measured: baseline and post-intervention (16 weeks)
Communication
Measured: baseline and post-intervention (16 weeks)
Relationship factors (dyad, family, social networks)
Measured: baseline and post-intervention (16 weeks)
Psychosocial factors
Measured: baseline and post-intervention (16 weeks)
Eating behavior
Measured: baseline and post-intervention (16 weeks)
Physical activity
Measured: baseline and post-intervention (16 weeks)
Weight control behavior
Measured: baseline and post-intervention (16 weeks)
Treatment attendance and adherence
Measured: between baseline and post-intervention (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study start1 Aug 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObeseStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Becky Marquez, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787902
- Sponsor's protocol ID
- 151345
- Status last verified
- Oct 2021
- First submitted
- 22 Feb 2016
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Communication and Collaboration for Weight Management in Mother-daughter
- ClinicalTrials.gov ID
- NCT02787902
- Acronym / sponsor ID
- 151345
- Conditions
- Overweight or Obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 1 Jun 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.
The purpose of this study is to develop, implement, and evaluate a behavioral weight management intervention with a communication training component for Mexican-American women. The study has three specific aims.
Aim 1: Develop a behavioral weight loss intervention that modifies evidence-based behavioral weight loss treatment using results from formative data collected from Mexican-American mother-daughter dyads. The adapted intervention will focus on improving dyadic communication and collaboration for providing reciprocal support for healthy eating and physical activity behaviors.
Aim 2: Implement and evaluate a pilot weight management program adapted for mother-daughter dyads. Dyads will be randomly assigned to partner-based treatment with or without communication skills training.
Aim 3: Evaluate associations between changes in weight, weight-related behaviors, and psychosocial variables with changes in measures assessing interpersonal communication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Communication | Experimental | Behavioral: CommunicationBehavioral weight loss program with communication skills training |
| Standard | Active comparator | Behavioral: StandardStandard behavioral weight loss program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- Body mass index of 25-50 kg/m2
- Mexican or Mexican-American
Key exclusion criteria (4 listed)
- Pregnancy or plans to become pregnant in the next year
- 5% weight loss in the last 3 months
- History of bariatric surgery
- Serious medical condition or psychological disorder
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 |
|---|---|---|
| CommunicationBehavioral weight management program adapted for mother-daughter dyads with communication skills training | Behavioural | Communication |
| StandardBehavioral weight management program adapted for mother-daughter dyads without communication skills training | Behavioural | Standard |
Primary outcome
Weight change
Time frame: 16 weeks
Change in weight from baseline to post-intervention (16 weeks).
9 secondary outcomes
Anthropometrics
Time frame: baseline and post-intervention (16 weeks)
Blood pressure
Time frame: baseline and post-intervention (16 weeks)
Communication
Time frame: baseline and post-intervention (16 weeks)
Relationship factors (dyad, family, social networks)
Time frame: baseline and post-intervention (16 weeks)
Psychosocial factors
Time frame: baseline and post-intervention (16 weeks)
Eating behavior
Time frame: baseline and post-intervention (16 weeks)
Physical activity
Time frame: baseline and post-intervention (16 weeks)
Weight control behavior
Time frame: baseline and post-intervention (16 weeks)
Treatment attendance and adherence
Time frame: between baseline and post-intervention (16 weeks)
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 12 Oct 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication and Standard in people with Overweight or Obese, run by University of California, San Diego 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 3 inclusion and 4 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 12 Oct 2021. 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 change (time frame: 16 weeks). 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 12 Oct 2021.