Obesity, ChildhoodNCT05032430
Reducing Maternal Stress to Improve Obesity-related Parenting Practices
A study testing CCC in people with Obesity, Childhood, run by American University at 1 site in United States.
Trial summary
Maternal stress is associated with children's risk for obesity controlling for socioeconomic status. The association between maternal stress and child obesity is particularly strong in Latinx families, whose children also have the highest rates of obesity in the United States. 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
- Obesity, Childhood
- What is being tested?
- CCC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2023to 14 Mar 2025
- 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
- over the age of 18 years
- identify as female
- identify as Hispanic or Latina
- have a child between the ages of 3 and 11 years who primarily resides with them
- able to understand basic instructions in either Spanish or English
Who cannot join
- pregnant or planning on becoming pregnant in the near future
- actively dependent on a substance
- have untreated psychosis, PTSD, or social anxiety that would impair their ability to function in a group setting
- child has an obesity-associated genetic syndrome
- child has a pervasive developmental disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
American University
Washington D.C., District of Columbia, 20016
About this study
Maternal stress is associated with children's risk for obesity controlling for socioeconomic status. The association between maternal stress and child obesity is particularly strong in Latinx families, whose children also have the highest rates of obesity in the United States. A mindful parenting program might reduce Latina mothers' psychological stress and lead to improved parenting practices and ability to create a healthier environment. The primary objective of the proposed research is to evaluate the feasibility and acceptability of a culturally-relevant intervention that integrates mindfulness-based stress reduction and mindful parenting in Latina mothers. The investigators will conduct a randomized clinical trial comparing the Calma, Conversa, y Cría (CCC) intervention to an active control condition in 50 Latina mothers of elementary-school age children. Participant satisfaction rates and qualitative interviews will provide evidence of the program's acceptability. Feasibility will be determined by examining recruitment rates, retention rates, and treatment fidelity. Completion of this project will inform the development of a full-scale efficacy trial.
- Conditions
- Obesity, Childhood
- Being tested
- CCC, Enhanced Usual Care
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCCBehavioural
A mix of mindfulness-based stress reduction, mindful eating, and mindful parenting strategies.
Enhanced Usual CareBehavioural
Consists of strategies meant to enhance health and well-being (e.g., health education, strategies to get more physical activity) but does not include mindfulness as an active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Calma, Conversa, y Cría (CCC) | Experimental | Mindfulness-based parental stress reduction intervention Receives: Behavioral: CCC |
| Enhanced Usual Care | Active comparator | Comparator group designed to influence health and well-being that does not include mindfulness as an active ingredient. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Satisfaction with Intervention Assessed by the Client Satisfaction Questionnaire
Parents will be asked to complete a brief, 8-item, widely used measure of satisfaction with health-related services, available in Spanish and English. Scores range from 8 to 32, with higher values indicating higher satisfaction.
Measured: Immediately after the intervention
Participant Retention
Research staff will take attendance during each intervention session.
Measured: At the beginning of each of the 6 weekly intervention sessions
Secondary outcomes (6)
Change in the Five Facet Mindfulness Questionnaire
The Five Facet Mindfulness Questionnaire (Spanish version) is a 39-item self-report measure of five facets of mindfulness: observing, describing, acting with awareness, non-judgment, and non-reactivity. Scores range from 39 to 190 with higher scores suggesting greater mindfulness.
Measured: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Change in the Perceived Stress Scale
The Perceived Stress Scale is a 10-item, widely used self-report measure of perceptions of psychological stress. Scores range from 0 to 40 with higher scores indicating greater perceived stress.
Measured: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Change in the Child Feeding Questionnaire
The Child Feeding Questionnaire is a 31-item self-report questionnaire that assesses parents' beliefs, attitudes, and approaches toward feeding their children. Scores range from 31 to 155 with higher scores representing greater use of controlling feeding practices.
Measured: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Change in the Frequency of Family Eating and Exercise Behaviors Questionnaire
28 items used in previous work by Neumark-Sztainer et al. will be used to assess eating and weight-related habits of families. Items assess: frequency of family meals, fast food consumption, and watching TV during meals; availability of fruits and vegetables and sugar sweetened beverages; and parents' encouragement of healthy food consumption and physical activity.
Measured: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Change in height in meters
Height will be measured to the nearest 0.1cm using a precision stadiometer.
Measured: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Change in weight in kilograms
Weight will be measured to the nearest 0.1kg using a digital scale.
Measured: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start25 Apr 2023
- Primary completion14 Jan 2025 (estimated)
- Study completion14 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Virginia Commonwealth University, George Washington University, Johns Hopkins University
- Responsible party
- Principal investigator, Elizabeth Cotter, American University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032430
- Sponsor's protocol ID
- IRB-220-317
- Other IDs
- K23AT011049
- Status last verified
- Jun 2024
- First submitted
- 10 Aug 2021
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Maternal Stress to Improve Obesity-related Parenting Practices
- ClinicalTrials.gov ID
- NCT05032430
- Acronym / sponsor ID
- IRB-220-317
- Conditions
- Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (actual)
- Lead sponsor
- American UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Virginia Commonwealth University, George Washington University, Johns Hopkins University
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 14 Jan 2025 (estimated)
- Study completion
- 14 Mar 2025 (estimated)
- First posted
- 2 Sep 2021 (actual)
- 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.
Maternal stress is associated with children's risk for obesity controlling for socioeconomic status. The association between maternal stress and child obesity is particularly strong in Latinx families, whose children also have the highest rates of obesity in the United States. A mindful parenting program might reduce Latina mothers' psychological stress and lead to improved parenting practices and ability to create a healthier environment. The primary objective of the proposed research is to evaluate the feasibility and acceptability of a culturally-relevant intervention that integrates mindfulness-based stress reduction and mindful parenting in Latina mothers. The investigators will conduct a randomized clinical trial comparing the Calma, Conversa, y Cría (CCC) intervention to an active control condition in 50 Latina mothers of elementary-school age children. Participant satisfaction rates and qualitative interviews will provide evidence of the program's acceptability. Feasibility will be determined by examining recruitment rates, retention rates, and treatment fidelity. Completion of this project will inform the development of a full-scale efficacy trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calma, Conversa, y Cría (CCC) | Experimental | Behavioral: CCCMindfulness-based parental stress reduction intervention |
| Enhanced Usual Care | Active comparator | Behavioral: Enhanced Usual CareComparator group designed to influence health and well-being that does not include mindfulness as an active ingredient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- over the age of 18 years
- identify as female
- identify as Hispanic or Latina
- have a child between the ages of 3 and 11 years who primarily resides with them
- able to understand basic instructions in either Spanish or English
Key exclusion criteria (5 listed)
- pregnant or planning on becoming pregnant in the near future
- actively dependent on a substance
- have untreated psychosis, PTSD, or social anxiety that would impair their ability to function in a group setting
- child has an obesity-associated genetic syndrome
- child has a pervasive developmental 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 |
|---|---|---|
| CCCA mix of mindfulness-based stress reduction, mindful eating, and mindful parenting strategies. | Behavioural | Calma, Conversa, y Cría (CCC) |
| Enhanced Usual CareConsists of strategies meant to enhance health and well-being (e.g., health education, strategies to get more physical activity) but does not include mindfulness as an active ingredient. | Behavioural | Enhanced Usual Care |
Primary outcome
Participant Satisfaction with Intervention Assessed by the Client Satisfaction Questionnaire
Time frame: Immediately after the intervention
Parents will be asked to complete a brief, 8-item, widely used measure of satisfaction with health-related services, available in Spanish and English. Scores range from 8 to 32, with higher values indicating higher satisfaction.
Participant Retention
Time frame: At the beginning of each of the 6 weekly intervention sessions
Research staff will take attendance during each intervention session.
6 secondary outcomes
Change in the Five Facet Mindfulness Questionnaire
Time frame: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Change in the Perceived Stress Scale
Time frame: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Change in the Child Feeding Questionnaire
Time frame: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Change in the Frequency of Family Eating and Exercise Behaviors Questionnaire
Time frame: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Change in height in meters
Time frame: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Change in weight in kilograms
Time frame: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- 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.
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 CCC in people with Obesity, Childhood, run by American University 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 Jun 2024. 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?
Results are not available in the source record.
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?
Participant Satisfaction with Intervention Assessed by the Client Satisfaction Questionnaire (time frame: Immediately after the intervention). The study lists 2 primary outcomes in all. 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 20 Jun 2024.