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Reducing Maternal Stress to Improve Obesity-related Parenting Practices

Reducing Maternal Stress to Improve Obesity-related Parenting Practices

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05032430
Enrollment
115
Registered
2021-09-02
Start date
2023-04-25
Completion date
2025-03-14
Last updated
2024-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Childhood

Brief 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. 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.

Interventions

BEHAVIORALCCC

A mix of mindfulness-based stress reduction, mindful eating, and mindful parenting strategies.

BEHAVIORALEnhanced Usual Care

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.

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
Virginia Commonwealth University
CollaboratorOTHER
George Washington University
CollaboratorOTHER
Johns Hopkins University
CollaboratorOTHER
American University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Participant Satisfaction with Intervention Assessed by the Client Satisfaction QuestionnaireImmediately after the interventionParents 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 RetentionAt the beginning of each of the 6 weekly intervention sessionsResearch staff will take attendance during each intervention session.

Secondary

MeasureTime frameDescription
Change in the Perceived Stress ScaleParticipants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baselineThe 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.
Change in the Five Facet Mindfulness QuestionnaireParticipants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baselineThe 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.
Change in the Child Feeding QuestionnaireParticipants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baselineThe 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.
Change in the Frequency of Family Eating and Exercise Behaviors QuestionnaireParticipants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline28 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.
Change in height in metersParticipants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baselineHeight will be measured to the nearest 0.1cm using a precision stadiometer.
Change in weight in kilogramsParticipants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baselineWeight will be measured to the nearest 0.1kg using a digital scale.

Other

MeasureTime frameDescription
Change in Child Quality of Life as Assessed by the Pediatric Health-Related Quality of Life QuestionnaireParticipants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baselineThe Pediatric Quality of Life Questionnaire is a 23-item measure of perceptions of how health affects daily life in 4 areas: physical, emotional, social, and school. Scores range from 0 - 100, with higher scores indicating greater quality of life.
Change in Child Weight in KilogramsParticipants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baselineWeight will be measured to the nearest 0.1kg using a digital scale.
Change in Child Height in MetersParticipants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baselineHeight will be measured to the nearest 0.1cm using a precision stadiometer.
Change in AccelerometryParticipants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baselineAccelerometers (Actigraph GT3X) will be worn for 1 week by children for each assessment period to assess physical activity objectively.
Change in Child Frequency of Physical Activity as Assessed by the Physical Activity Recall ScreenParticipants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baselineChildren's frequency of physical activity will be assessed using the Physical Activity Recall. This interview measure asks respondents to report the amount of time they spent in moderate and vigorous activities during the previous 7 days.
Change in Child Daily Kilocalories via 3-Day Food RecordParticipants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baselineParticipants will be trained to complete a 3-day food record (using a detailed food record form) to track dietary intake for 2 weekdays and 1 weekend day in the week prior to their assessment. Diet will be analyzed via Nutrition Data System Software (NDSR). Average kilocalories per day will be the primary dietary outcome.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026