An interventional study of CCC and Enhanced Usual Care in Obesity, Childhood, sponsored by American University. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-20.
Sponsored by American University · Not applicable, Interventional, and Other
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 115 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
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Exclusion Criteria:
Mindfulness-based parental stress reduction intervention
Behavioral: CCC
Comparator group designed to influence health and well-being that does not include mindfulness as an active ingredient.
Behavioral: Enhanced Usual Care
A mix of mindfulness-based stress reduction, mindful eating, and mindful parenting strategies.
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.
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.
Time frame: Immediately after the intervention
Participant Retention
Research staff will take attendance during each intervention session.
Time frame: At the beginning of each of the 6 weekly intervention sessions
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.
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
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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Change in Child Daily Kilocalories via 3-Day Food Record
Participants 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.
Time frame: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Change in Child Frequency of Physical Activity as Assessed by the Physical Activity Recall Screen
Children'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.
Time frame: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Change in Child Quality of Life as Assessed by the Pediatric Health-Related Quality of Life Questionnaire
The 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.
Time frame: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Change in Child Weight in Kilograms
Weight will be measured to the nearest 0.1kg using a digital scale.
Time frame: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Change in Child Height in Meters
Height will be measured to the nearest 0.1cm using a precision stadiometer.
Time frame: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Change in Accelerometry
Accelerometers (Actigraph GT3X) will be worn for 1 week by children for each assessment period to assess physical activity objectively.
Time frame: Participants will complete this at three timepoints: baseline, immediately after the intervention, and 10-months from baseline
Plan to share: Undecided
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This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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