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| ID | Type | Description | Link |
|---|---|---|---|
| R34AT010661 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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+).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feasibility and acceptability of ADAPT+ | Experimental | ADAPT+ is a family-based obesity intervention for high-risk Latino youth and their parents living in rural communities that incorporates culture-specific components and mindfulness-based approaches to promote adaptive health behaviors in a high-risk and underserved population. |
|
| Enhanced Usual Care (EUC) | Active Comparator | Enhanced Usual Care (EUC) provides publicly available material in both English and Spanish on the role of diet and exercise in pediatric obesity in a one-time information session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | 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. | 6 weeks after baseline |
| Feasibility - Accrual Rates | Percent of families approached who agreed to participate. This was done at the parent/dyad level. | 6 weeks after baseline |
| Feasibility - Number of Participants Attending 75%+ Sessions | Number of participants who completed at least 75% of the program sessions. This was done at the parent/dyad level. | 6 weeks after baseline |
| Retention Over Time (From Baseline to Post-assessment) | Percentage of families retained for post-intervention assessment | From baseline to post-assessment (6-weeks) |
| Retention Over Time (From Baseline to 3-month Follow-up) | Percentage of families retained for 3-month follow-up assessment | From baseline to 3-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Child BMI z Score (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. | Post-Assessment (6 weeks after Baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marilyn Stern, PhD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hispanic Services Council | Tampa | Florida | 33614 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24570244 | Background | Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732. | |
| 26478602 | Background | Lichter DT. Immigration and the New Racial Diversity in Rural America. Rural Sociol. 2012 Mar;77(1):3-35. doi: 10.1111/j.1549-0831.2012.00070.x. Epub 2012 Mar 1. |
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A total of 48 parent/child dyad pairs were considered enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Feasibility and Acceptability of ADAPT+ | ADAPT+ is a family-based obesity intervention for high-risk Latino youth and their parents living in rural communities that incorporates culture-specific components and mindfulness-based approaches to promote adaptive health behaviors in a high-risk and underserved population. ADAPT+: ADAPT+ is designed as a 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. |
| FG001 | Enhanced Usual Care (EUC) | Enhanced Usual Care (EUC) provides publicly available material in both English and Spanish on the role of diet and exercise in pediatric obesity in a one-time information session. EUC: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Feasibility and Acceptability of ADAPT+ | ADAPT+ is a family-based obesity intervention for high-risk Latino youth and their parents living in rural communities that incorporates culture-specific components and mindfulness-based approaches to promote adaptive health behaviors in a high-risk and underserved population. ADAPT+: ADAPT+ is designed as an 8-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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The overall number of participants includes both parents and children participating in the study. A row was created for each group (i.e., one row for parents and one row for children), in order to report Mean and SD values accordingly. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acceptability | 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. | This number refers to the parents who completed the exit survey. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks after baseline |
|
19 weeks
NIH's definition of adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Feasibility and Acceptability of ADAPT+ | ADAPT+ is a family-based obesity intervention for high-risk Latino youth and their parents living in rural communities that incorporates culture-specific components and mindfulness-based approaches to promote adaptive health behaviors in a high-risk and underserved population. ADAPT+: ADAPT+ is designed as a 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. |
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This study was a feasibility and acceptability pilot and was not powered to test the efficacy of our intervention, ADAPT+. The study results are preliminary in nature. Other key limitations are that participating parents primarily were mothers and that the study was geographically limited to only two rural communities where the project was implemented. COVID-19 also affected some of the recruitment efforts and did, at times, impact participant's attendance to sessions and assessments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tatyana Harris | University of South Florida | (813) 974-7454 | trharris1@usf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 19, 2021 | Jan 12, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D000064 | Acclimatization |
| ID | Term |
|---|---|
| D000222 | Adaptation, Physiological |
| D010829 | Physiological Phenomena |
| D000220 | Adaptation, Biological |
| D001686 | Biological Phenomena |
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Aim 2 includes randomization to a comparison group - 48 parent-child dyads (96 individuals) anticipated for enrollment.
Aim 2 was the small pilot RCT
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|
| 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. |
|
| Child BMI z Score (3-month Follow-up) | 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-month Follow-up (3 months after Post-Assessment) |
| Child Waist-to-Hip Ratio (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. | Post-Assessment (6 weeks after Baseline) |
| Child Waist-to-Hip Ratio (3-month Follow-up) | 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. | 3-month Follow-up (3 months after Post-Assessment) |
| Child Sugar Sweet Beverage and Fast Food Intake Instrument (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 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. | Post-Assessment (6 weeks after Baseline) |
| Child Sugar Sweet Beverage and Fast Food Intake Instrument (3-month Follow-up) | 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. | 3-month Follow-up (3 months after Post-Assessment) |
| Parent BMI (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. | Post-Assessment (6 weeks after Baseline) |
| Parent BMI (3-month Follow-up) | 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. | 3-month Follow-up (3 months after Post-Assessment) |
| Parent Waist-to-Hip Ratio (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. | Post-Assessment (6 weeks after Baseline) |
| Parent Waist-to-Hip Ratio (3-month Follow-up) | 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. | 3-month Follow-up (3 months after Post-Assessment) |
| Latino Dietary Behaviors Questionnaire (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. | Post-Assessment (6 weeks after Baseline) |
| Latino Dietary Behaviors Questionnaire (3-month Follow-up) | 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. | 3-month Follow-up (3 months after Post-Assessment) |
| Perceived Stress Scale (PSS) [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. | Post-Assessment (6 weeks after Baseline) |
| Perceived Stress Scale (PSS) [3-month Follow-up] | 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. | 3-month Follow-up (3 months after Post-Assessment) |
| Recognize Subscale of the Mindful Eating Questionnaire (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. | Post-Assessment (6 weeks after Baseline) |
| Recognize Subscale of the Mindful Eating Questionnaire (3-month Follow-up) | 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. | 3-month Follow-up (3 months after Post-Assessment) |
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| BG001 | Enhanced Usual Care (EUC) | Enhanced Usual Care (EUC) provides publicly available material in both English and Spanish on the role of diet and exercise in pediatric obesity in a one-time information session. EUC: 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | The overall number of participants represents participating parents and children. Row population was created to represent each age group (e.g., parents, youth). | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | The overall number of participants represents participating parents and children. Row population was created to represent each age group (e.g., parents, youth). | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI (parent) | Row population differs from Overall because BMI was only calculated for participating parents. | Mean | Standard Deviation | kg/m^2 |
|
| BMI z-score (child) | 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. | Row population differs from Overall because z-BMI was only calculated for participating children. | Mean | Standard Deviation | Z-score |
|
| Waist-to-hip ratio (WHR) (parent) | Row population differs from Overall because this variable represents the waist-to-hip ratio for participating parents only. | Mean | Standard Deviation | Waist-to-hip ratio |
|
| Waist-to-hip ratio (WHR) (child) | Row population differs from Overall because this variable represents the waist-to-hip ratio for participating children only. | Mean | Standard Deviation | Waist-to-hip ratio |
|
| Resting blood pressure (parent) | Row population differs from Overall because this variable represents the blood pressure data for participating parents only. | Mean | Standard Deviation | millimeters of mercury (mmHg) |
|
| Resting blood pressure (child) | Row population differs from Overall because this variable represents the blood pressure data for participating children only. | Mean | Standard Deviation | millimeters of mercury (mmHg) |
|
| Child Sugar Sweet Beverage and Fast Food Intake Instrument (child) | 11 items on food and physical activity behaviors for youth. 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 Freq (SSB): 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. | Row population differs from Overall because this measure was only assessed in participating children. | Mean | Standard Deviation | units on a scale |
|
| Stephenson Multigroup Acculturation Scale [SMAS] (parent) | Row population differs from Overall because this variable represents the acculturation data asked only to participating parents. | Mean | Standard Deviation | units on a scale |
|
| Latino Dietary Behaviors Questionnaire (parent) | Row population differs from Overall because this measure was only assessed in participating parents. | Mean | Standard Deviation | units on a scale |
|
| Perceived Stress Scale (PSS) (parent) | Row population differs from Overall because this measure was only assessed in participating parents. | Mean | Standard Deviation | units on a scale |
|
| Recognize subscale of the Mindful Eating Questionnaire (parent) | Row population differs from Overall because this measure was only assessed in participating parents. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Enhanced Usual Care (EUC) | Enhanced Usual Care (EUC) provides publicly available material in both English and Spanish on the role of diet and exercise in pediatric obesity in a one-time information session. EUC: 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 | Feasibility - Accrual Rates | Percent of families approached who agreed to participate. This was done at the parent/dyad level. | This number refers to the parent-child dyads. | Posted | Count of Participants | Participants | 6 weeks after baseline |
|
|
|
| Primary | Feasibility - Number of Participants Attending 75%+ Sessions | Number of participants who completed at least 75% of the program sessions. This was done at the parent/dyad level. | Posted | Count of Participants | Participants | 6 weeks after baseline |
|
|
|
| Primary | Retention Over Time (From Baseline to Post-assessment) | Percentage of families retained for post-intervention assessment | Posted | Count of Participants | Participants | From baseline to post-assessment (6-weeks) |
|
|
|
| Primary | Retention Over Time (From Baseline to 3-month Follow-up) | Percentage of families retained for 3-month follow-up assessment | Posted | Count of Participants | Participants | From baseline to 3-month follow-up |
|
|
|
| Secondary | Child BMI z Score (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. | Posted | Mean | Standard Deviation | Z-score | Post-Assessment (6 weeks after Baseline) |
|
|
|
| Secondary | Child BMI z Score (3-month Follow-up) | 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. | Posted | Mean | Standard Deviation | Z-score | 3-month Follow-up (3 months after Post-Assessment) |
|
|
|
| Secondary | Child Waist-to-Hip Ratio (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. | Posted | Mean | Standard Deviation | Waist-to-Hip Ratio | Post-Assessment (6 weeks after Baseline) |
|
|
|
| Secondary | Child Waist-to-Hip Ratio (3-month Follow-up) | 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. | Posted | Mean | Standard Deviation | Waist-to-Hip Ratio | 3-month Follow-up (3 months after Post-Assessment) |
|
|
|
| Secondary | Child Sugar Sweet Beverage and Fast Food Intake Instrument (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 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. | Posted | Mean | Standard Deviation | score on a scale | Post-Assessment (6 weeks after Baseline) |
|
|
|
| Secondary | Child Sugar Sweet Beverage and Fast Food Intake Instrument (3-month Follow-up) | 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. | Posted | Mean | Standard Deviation | score on a scale | 3-month Follow-up (3 months after Post-Assessment) |
|
|
|
| Secondary | Parent BMI (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. | Posted | Mean | Standard Deviation | kg/m^2 | Post-Assessment (6 weeks after Baseline) |
|
|
|
| Secondary | Parent BMI (3-month Follow-up) | 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. | Posted | Mean | Standard Deviation | kg/m2 | 3-month Follow-up (3 months after Post-Assessment) |
|
|
|
| Secondary | Parent Waist-to-Hip Ratio (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. | Posted | Mean | Standard Deviation | Waist-to-Hip Ratio | Post-Assessment (6 weeks after Baseline) |
|
|
|
| Secondary | Parent Waist-to-Hip Ratio (3-month Follow-up) | 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. | Posted | Mean | Standard Deviation | Waist-to-Hip Ratio | 3-month Follow-up (3 months after Post-Assessment) |
|
|
|
| Secondary | Latino Dietary Behaviors Questionnaire (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. | Posted | Mean | Standard Deviation | score on a scale | Post-Assessment (6 weeks after Baseline) |
|
|
|
| Secondary | Latino Dietary Behaviors Questionnaire (3-month Follow-up) | 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. | Posted | Mean | Standard Deviation | score on a scale | 3-month Follow-up (3 months after Post-Assessment) |
|
|
|
| Secondary | Perceived Stress Scale (PSS) [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. | Posted | Mean | Standard Deviation | score on a scale | Post-Assessment (6 weeks after Baseline) |
|
|
|
| Secondary | Perceived Stress Scale (PSS) [3-month Follow-up] | 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. | Posted | Mean | Standard Deviation | score on a scale | 3-month Follow-up (3 months after Post-Assessment) |
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|
|
| Secondary | Recognize Subscale of the Mindful Eating Questionnaire (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. | Posted | Mean | Standard Deviation | score on a scale | Post-Assessment (6 weeks after Baseline) |
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|
|
| Secondary | Recognize Subscale of the Mindful Eating Questionnaire (3-month Follow-up) | 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. | Posted | Mean | Standard Deviation | score on a scale | 3-month Follow-up (3 months after Post-Assessment) |
|
|
|
| 0 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | Enhanced Usual Care (EUC) | Enhanced Usual Care (EUC) provides publicly available material in both English and Spanish on the role of diet and exercise in pediatric obesity in a one-time information session. EUC: 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. | 0 | 48 | 0 | 48 | 0 | 48 |
Not provided
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
|
| Unknown or Not Reported |
|
| More than one race |
|
| Other race |
|
| Unknown |
|
| Black |
|
| More than one race |
|
| Other race |
|
| Unknown |
|
| Sugar-Sweetened Beverage: Frequency |
|
| Sugar-Sweetened Beverage: Quantity |
|
| Fast Food: Frequency |
|
| Fast Food: Quantity |
|
| Sugar-Sweetened Beverage: Frequency |
|
| Sugar-Sweetened Beverage: Quantity |
|
| Fast Food: Frequency |
|
| Fast Food: Quantity |
|