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Completed

NCT Number: NCT04800432

Adapting Diet and Action for Everyone (ADAPT+)

The purpose of this study is to refine and optimize an obesity intervention with rural underserved Latino children and their parents that combines a standard family-based behavioral approach, the "gold standard" for pediatric obesity treatment, with a mindfulness approach focusing on stress reduction (now ADAPT+).

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Key information

Conditions

Pediatric Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hispanic Services Council

Tampa, Florida, 33614, United States

About this study

Latino youth have the highest prevalence of obesity as compared to Black or White youth, and are at high risk for adult obesity-related complications including cardiovascular disease. Moreover, Latino youth living in rural communities have an increased risk of adult obesity and mortality due to obesity-related chronic disease than Latinos living elsewhere. The investigators synthesized the prior childhood obesity intervention and tailored the evidence informed, theory-based, multi-family behavioral intervention, Adapting Diet and Action for Everyone (ADAPT), to the acculturation status, language, and national origin of the target population - obese, school-aged (8-12 years old) Latino youth and their parents living in rural areas. However, because the role of parent stress on obesity has not been adequately addressed in interventions aimed at reducing obesity in Latino youth, it is argued that mindfulness parent stress reduction strategies may be a key component to improving eating and physical activity (PA) behaviors in both children and their parents. This study proposes a refinement and optimization of the original ADAPT obesity intervention protocol to include mindfulness parent stress reduction strategies (now ADAPT+) and feasibility assessment of ADAPT+ implementation.

Aim 1: Refinement of ADAPT+ (ADAPT + mindfulness parent stress reduction). Aim 1A and Aim 1B were focus groups with promotoras from the target communities and parents. The intervention manual was refined based on the qualitative feedback. Aim 1C further refines the manual via a small one parent-child cohort. Data collected at Aim 1C was used to finalize and optimize a culturally acceptable ADAPT+ evaluated in Aim 2.

Aim 2: Feasibility and Acceptability trial. A randomized trial testing feasibility of ADAPT+ vs. Enhanced Usual Care (EUC) conducted in two rural communities. It is anticipated that compared to EUC, ADAPT+ dyads will have a lower attrition rate and will report greater satisfaction. The investigators also explore whether the eating and stress indices are sensitive to the intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Child with a BMI %ile of 85 or higher.
  • The target parent is at least 18 years old, is the main meal preparer, speaks and reads Spanish at a minimum of a 4th grade reading level (able to follow basic instructions in Spanish), and able to perform simple physical exercises.

Exclusion criteria

  • A child who has a medical/developmental condition that precludes weight loss using conventional diet and PA methods.
  • A child has been on antibiotics or steroids in the previous three months.
  • The parent is ineligible if he/she is non-ambulatory, is pregnant, or has a medical condition that may be negatively impacted by PA.

Treatment and study plan

ADAPT+

Behavioral

ADAPT+ is designed as an 6-week intervention. For each session, children and parents participate in separate 1.5-hour group meetings, followed by a joint goal setting session. Practical strategies related to improving diet and physical activity as well as the role of dealing with parent stress-related factors related to making long-lasting behavioral changes in the family are addressed.

EUC

Behavioral

Enhanced Usual Care is an abbreviated version of the full ADAPT+ intervention in which parents are engaged in a one-time, two hour information session to also learn knowledge and skills to improve the health and lifestyle behaviors for their child and for themselves.

Primary outcomes

  1. Acceptability

    Time frame: 6 weeks after baseline

    Acceptability was measured by a program satisfaction survey at the end of the intervention. Items were rated on a scale from 1 (Not at all) to 4 (Very) enjoyable, comfortable, receptive, relevant, or helpful, depending on the item's content. A mean score was calculated using all items to reflect overall satisfaction, with higher scores indicating greater satisfaction. Only parents completed the program satisfaction survey.

    Minimum score: 1 Maximum score: 4 Higher scores mean better outcomes.

  2. Feasibility - Accrual Rates

    Time frame: 6 weeks after baseline

    Percent of families approached who agreed to participate. This was done at the parent/dyad level.

  3. Feasibility - Number of Participants Attending 75%+ Sessions

    Time frame: 6 weeks after baseline

    Number of participants who completed at least 75% of the program sessions. This was done at the parent/dyad level.

  4. Retention Over Time (From Baseline to Post-assessment)

    Time frame: From baseline to post-assessment (6-weeks)

    Percentage of families retained for post-intervention assessment

  5. Retention Over Time (From Baseline to 3-month Follow-up)

    Time frame: From baseline to 3-month follow-up

    Percentage of families retained for 3-month follow-up assessment

Secondary outcomes

  1. Child BMI z Score (Post-Assessment)

    Time frame: Post-Assessment (6 weeks after Baseline)

    Height (to the nearest 1/4 inch) using a metal ruler and weight (to the nearest 1/4 pound) using a scale will be measured by study staff.

    Z Body Mass Index (BMI). 0 represents the population mean. The higher the score, the higher the BMI, based on age and gender. There are no established clinically relevant thresholds for z-BMI.

  2. Child BMI z Score (3-month Follow-up)

    Time frame: 3-month Follow-up (3 months after Post-Assessment)

    Height (to the nearest 1/4 inch) using a metal ruler and weight (to the nearest 1/4 pound) using a scale will be measured by study staff.

    Z Body Mass Index (BMI). 0 represents the population mean. The higher the score, the higher the BMI, based on age and gender. There are no established clinically relevant thresholds for z-BMI.

  3. Child Waist-to-Hip Ratio (Post-Assessment)

    Time frame: Post-Assessment (6 weeks after Baseline)

    Circumference of the hip (girth of hips above the gluteal fold) and waist (narrowest part of torso above the umbilicus and below the xiphoid process) will be measured by study staff using an anthropometric measuring tape and used to calculate continuous Waist-to-Hip Ratio.

  4. Child Waist-to-Hip Ratio (3-month Follow-up)

    Time frame: 3-month Follow-up (3 months after Post-Assessment)

    Circumference of the hip (girth of hips above the gluteal fold) and waist (narrowest part of torso above the umbilicus and below the xiphoid process) will be measured by study staff using an anthropometric measuring tape and used to calculate continuous Waist-to-Hip Ratio.

  5. Child Sugar Sweet Beverage and Fast Food Intake Instrument (Post-Assessment)

    Time frame: Post-Assessment (6 weeks after Baseline)

    The questionnaire consists of 11 questions on food and physical activity behaviors for youth participants in the study. This was adapted from the Youth Expanded Food and Nutrition Education Program (EFNEP) evaluation tool, the EFNEP 3rd-5th Grade Survey, which was designed and tested by Purdue University Extension Program. It will take approximately 5 minutes to complete. Below are presented the minimum and maximum values for each subscale reported.

    Fruit & Veg Frequency: 0-15, higher scores mean fruits and veggies consumed more frequently.

    Fruit & Veg Quantity: 0-5, higher scores mean larger fruit and veggie quantity consumed.

    Sugar-Sweetened Beverage Frequency: 0-8, higher scores mean SSB consumed more frequently.

    Sugar-Sweetened Beverage Quantity: 0-5, higher scores mean larger quantities of SSB consumed.

    Fast Food Frequency: 0-4, higher scores mean fast food consumed more frequently.

    Fast Food Quantity: 0-16, higher scores mean larger quantities of fast food consumed.

  6. Child Sugar Sweet Beverage and Fast Food Intake Instrument (3-month Follow-up)

    Time frame: 3-month Follow-up (3 months after Post-Assessment)

    The questionnaire consists of 11 questions on food and physical activity behaviors for youth participants in the study. This was adapted from the USDA Youth Expanded Food and Nutrition Education Program (EFNEP) evaluation tool, the EFNEP 3rd-5th Grade Survey, which was designed and tested by Purdue University Extension Program. It will take approximately 5 minutes to complete. Below are presented the minimum and maximum values for each subscale reported.

    Fruit & Veg Frequency: 0-15, higher scores mean fruits and veggies consumed more frequently.

    Fruit & Veg Quantity: 0-5, higher scores mean larger fruit and veggie quantity consumed.

    Sugar-Sweetened Beverage Frequency: 0-8, higher scores mean SSB consumed more frequently.

    Sugar-Sweetened Beverage Quantity: 0-5, higher scores mean larger quantities of SSB consumed.

    Fast Food Frequency: 0-4, higher scores mean fast food consumed more frequently.

    Fast Food Quantity: 0-16, higher scores mean larger quantities of fast food consumed.

  7. Parent BMI (Post-Assessment)

    Time frame: Post-Assessment (6 weeks after Baseline)

    Height (to the nearest 1/4 inch) using a metal ruler and weight (to the nearest 1/4 pound) using a scale will be measured by the study staff and used to calculate continuous adult BMI score.

  8. Parent BMI (3-month Follow-up)

    Time frame: 3-month Follow-up (3 months after Post-Assessment)

    Height (to the nearest 1/4 inch) using a metal ruler and weight (to the nearest 1/4 pound) using a scale will be measured by the study staff and used to calculate continuous adult BMI score.

  9. Parent Waist-to-Hip Ratio (Post-Assessment)

    Time frame: Post-Assessment (6 weeks after Baseline)

    Circumference of the hip (girth of hips above the gluteal fold) and waist (narrowest part of torso above the umbilicus and below the xiphoid process) will be measured by the study staff using an anthropometric measuring tape and used to calculate continuous Waist-to-Hip Ratio.

  10. Parent Waist-to-Hip Ratio (3-month Follow-up)

    Time frame: 3-month Follow-up (3 months after Post-Assessment)

    Circumference of the hip (girth of hips above the gluteal fold) and waist (narrowest part of torso above the umbilicus and below the xiphoid process) will be measured by the study staff using an anthropometric measuring tape and used to calculate continuous Waist-to-Hip Ratio.

  11. Latino Dietary Behaviors Questionnaire (Post-Assessment)

    Time frame: Post-Assessment (6 weeks after Baseline)

    The Latino Dietary Behaviors Questionnaire: This 13-item self-report survey of dietary habits (in Spanish) assesses 4 areas of eating behavior -- healthy dietary changes; types of drinks consumed, number of meals per day and fat consumption. Minimum and maximum scores possible for this scale range from 1 to 47. Higher scores reflect healthier eating behaviors.

  12. Latino Dietary Behaviors Questionnaire (3-month Follow-up)

    Time frame: 3-month Follow-up (3 months after Post-Assessment)

    The Latino Dietary Behaviors Questionnaire: This 13-item self-report survey of dietary habits (in Spanish) assesses 4 areas of eating behavior -- healthy dietary changes; types of drinks consumed, number of meals per day and fat consumption. Minimum and maximum scores possible for this scale range from 1 to 47. Higher scores reflect healthier eating behaviors.

  13. Perceived Stress Scale (PSS) [Post-Assessment]

    Time frame: Post-Assessment (6 weeks after Baseline)

    Parents complete the 14 item self-report scale that asks participants about their feelings in the past month. Minimum and maximum scores possible for this scale range from 0 to 40. Higher scores reflect greater perceived stress.

  14. Perceived Stress Scale (PSS) [3-month Follow-up]

    Time frame: 3-month Follow-up (3 months after Post-Assessment)

    Parents complete the 14 item self-report scale that asks participants about their feelings in the past month. Minimum and maximum scores possible for this scale range from 0 to 40. Higher scores reflect greater perceived stress.

  15. Recognize Subscale of the Mindful Eating Questionnaire (Post-Assessment)

    Time frame: Post-Assessment (6 weeks after Baseline)

    Parents will complete the Recognize subscale of the Mindful Eating Questionnaire. The subscale has 9 items and is designed to assess an individual's ability to stop eating when full. Minimum and maximum scores possible for this subscale range from 9 to 36. Higher scores reflect a greater degree of recognition of hunger and satiety cues.

  16. Recognize Subscale of the Mindful Eating Questionnaire (3-month Follow-up)

    Time frame: 3-month Follow-up (3 months after Post-Assessment)

    Parents will complete the Recognize subscale of the Mindful Eating Questionnaire. The subscale has 9 items and is designed to assess an individual's ability to stop eating when full. Minimum and maximum scores possible for this subscale range from 9 to 36. Higher scores reflect a greater degree of recognition of hunger and satiety cues.

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

ADAPT+: Optimizing an Intervention to Promote Healthy Behaviors in Rural, Latino Youth With Obesity and Their Parents, Using Mindfulness Strategies

Acronym: ADAPT+

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 16, 2021
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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