Pediatric ObesityADAPT+NCT04800432
Adapting Diet and Action for Everyone (ADAPT+)
A study testing ADAPT+ and EUC in people with Pediatric Obesity, run by University of South Florida at 1 site in United States.
Trial summary
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+). Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- ADAPT+ and EUC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2021to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ADAPT+: Optimizing an Intervention to Promote Healthy Behaviors in Rural, Latino Youth With Obesity and Their Parents, Using Mindfulness Strategies
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+).
Read the detailed description
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.
- Conditions
- Pediatric Obesity
- Being tested
- ADAPT+, EUC
- Keywords
- Latino, Rural Communities, Mindfulness
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADAPT+Behavioural
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.
EUCBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: ADAPT+ |
| 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. Receives: Behavioral: EUC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks after baseline
Feasibility - Accrual Rates
Percent of families approached who agreed to participate. This was done at the parent/dyad level.
Measured: 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.
Measured: 6 weeks after baseline
Retention Over Time (From Baseline to Post-assessment)
Percentage of families retained for post-intervention assessment
Measured: 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
Measured: From baseline to 3-month follow-up
Secondary outcomes (16)
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.
Measured: Post-Assessment (6 weeks after Baseline)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3-month Follow-up (3 months after Post-Assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start6 Mar 2021
- Primary completion30 Sep 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (96)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Aim 2 includes randomization to a comparison group - 48 parent-child dyads (96 individuals) anticipated for enrollment. Aim 2 was the small pilot RCT
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Marilyn Stern, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800432
- Sponsor's protocol ID
- Pro00039979
- Other IDs
- R34AT010661
- Acronym
- ADAPT+
- Status last verified
- Mar 2024
- First submitted
- 24 Feb 2021
- Last updated
- 17 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24570244Lichter 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.
PubMed 26478602Bates LM, Acevedo-Garcia D, Alegria M, Krieger N. Immigration and generational trends in body mass index and obesity in the United States: results of the National Latino and Asian American Survey, 2002-2003. Am J Public Health. 2008 Jan;98(1):70-7. doi: 10.2105/AJPH.2006.102814. Epub 2007 Nov 29.
PubMed 18048787Haldeman GA, Croft JB, Giles WH, Rashidee A. Hospitalization of patients with heart failure: National Hospital Discharge Survey, 1985 to 1995. Am Heart J. 1999 Feb;137(2):352-60. doi: 10.1053/hj.1999.v137.95495.
PubMed 9924171Lutfiyya MN, Lipsky MS, Wisdom-Behounek J, Inpanbutr-Martinkus M. Is rural residency a risk factor for overweight and obesity for U.S. children? Obesity (Silver Spring). 2007 Sep;15(9):2348-56. doi: 10.1038/oby.2007.278.
PubMed 17890504Jilcott SB, Wade S, McGuirt JT, Wu Q, Lazorick S, Moore JB. The association between the food environment and weight status among eastern North Carolina youth. Public Health Nutr. 2011 Sep;14(9):1610-7. doi: 10.1017/S1368980011000668. Epub 2011 Apr 13.
PubMed 21486525Wang Y, Beydoun MA. The obesity epidemic in the United States--gender, age, socioeconomic, racial/ethnic, and geographic characteristics: a systematic review and meta-regression analysis. Epidemiol Rev. 2007;29:6-28. doi: 10.1093/epirev/mxm007. Epub 2007 May 17.
PubMed 17510091Butte NF, Cai G, Cole SA, Comuzzie AG. Viva la Familia Study: genetic and environmental contributions to childhood obesity and its comorbidities in the Hispanic population. Am J Clin Nutr. 2006 Sep;84(3):646-54; quiz 673-4. doi: 10.1093/ajcn/84.3.646.
PubMed 16960181Stovitz SD, Schwimmer JB, Martinez H, Story MT. Pediatric obesity: the unique issues in Latino-American male youth. Am J Prev Med. 2008 Feb;34(2):153-60. doi: 10.1016/j.amepre.2007.09.034.
PubMed 18201646Wenten M, Gilliland FD, Baumgartner K, Samet JM. Associations of weight, weight change, and body mass with breast cancer risk in Hispanic and non-Hispanic white women. Ann Epidemiol. 2002 Aug;12(6):435-4. doi: 10.1016/s1047-2797(01)00293-9.
PubMed 12160603Golan M, Crow S. Targeting parents exclusively in the treatment of childhood obesity: long-term results. Obes Res. 2004 Feb;12(2):357-61. doi: 10.1038/oby.2004.45.
PubMed 14981230Janicke DM, Steele RG, Gayes LA, Lim CS, Clifford LM, Schneider EM, Carmody JK, Westen S. Systematic review and meta-analysis of comprehensive behavioral family lifestyle interventions addressing pediatric obesity. J Pediatr Psychol. 2014 Sep;39(8):809-25. doi: 10.1093/jpepsy/jsu023. Epub 2014 May 13.
PubMed 24824614Isasi CR, Hua S, Jung M, Carnethon MR, Perreira K, Vidot DC, Salazar CR, McCurley JL, Sotres-Alvarez D, Van Horn L, Delamater AM, Llabre MM, Gallo LC. The Association of Parental/Caregiver Chronic Stress with Youth Obesity: Findings from the Study of Latino Youth and the Hispanic Community Health Study/Study of Latinos Sociocultural Ancillary Study. Child Obes. 2017 Aug;13(4):251-258. doi: 10.1089/chi.2016.0205. Epub 2017 Mar 1.
PubMed 28398853Tsenkova V, Boylan JM, Ryff C. Stress eating and health. Findings from MIDUS, a national study of US adults. Appetite. 2013 Oct;69:151-5. doi: 10.1016/j.appet.2013.05.020. Epub 2013 Jun 6.
PubMed 23747576Block JP, He Y, Zaslavsky AM, Ding L, Ayanian JZ. Psychosocial stress and change in weight among US adults. Am J Epidemiol. 2009 Jul 15;170(2):181-92. doi: 10.1093/aje/kwp104. Epub 2009 May 22.
PubMed 19465744
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADAPT+: Optimizing an Intervention to Promote Healthy Behaviors in Rural, Latino Youth With Obesity and Their Parents, Using Mindfulness Strategies
- ClinicalTrials.gov ID
- NCT04800432
- Acronym / sponsor ID
- ADAPT+ / Pro00039979
- Conditions
- Pediatric Obesity
- Keywords
- Latino, Rural Communities, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 6 Mar 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 16 Mar 2021 (actual)
- Results
- Posted 17 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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+).
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Aim 2 includes randomization to a comparison group - 48 parent-child dyads (96 individuals) anticipated for enrollment. Aim 2 was the small pilot RCT
| Arm | Type | Receives |
|---|---|---|
| Feasibility and acceptability of ADAPT+ | Experimental | Behavioral: 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. |
| Enhanced Usual Care (EUC) | Active comparator | Behavioral: EUCEnhanced 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| ADAPT+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. | Behavioural | Feasibility and acceptability of ADAPT+ |
| EUCEnhanced 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. | Behavioural | Enhanced Usual Care (EUC) |
Primary outcome
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.
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.
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.
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
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
16 secondary outcomes
Child BMI z Score (Post-Assessment)
Time frame: Post-Assessment (6 weeks after Baseline)
Child BMI z Score (3-month Follow-up)
Time frame: 3-month Follow-up (3 months after Post-Assessment)
Child Waist-to-Hip Ratio (Post-Assessment)
Time frame: Post-Assessment (6 weeks after Baseline)
Child Waist-to-Hip Ratio (3-month Follow-up)
Time frame: 3-month Follow-up (3 months after Post-Assessment)
Child Sugar Sweet Beverage and Fast Food Intake Instrument (Post-Assessment)
Time frame: Post-Assessment (6 weeks after Baseline)
Child Sugar Sweet Beverage and Fast Food Intake Instrument (3-month Follow-up)
Time frame: 3-month Follow-up (3 months after Post-Assessment)
Parent BMI (Post-Assessment)
Time frame: Post-Assessment (6 weeks after Baseline)
Parent BMI (3-month Follow-up)
Time frame: 3-month Follow-up (3 months after Post-Assessment)
Parent Waist-to-Hip Ratio (Post-Assessment)
Time frame: Post-Assessment (6 weeks after Baseline)
Parent Waist-to-Hip Ratio (3-month Follow-up)
Time frame: 3-month Follow-up (3 months after Post-Assessment)
Latino Dietary Behaviors Questionnaire (Post-Assessment)
Time frame: Post-Assessment (6 weeks after Baseline)
Latino Dietary Behaviors Questionnaire (3-month Follow-up)
Time frame: 3-month Follow-up (3 months after Post-Assessment)
Perceived Stress Scale (PSS) [Post-Assessment]
Time frame: Post-Assessment (6 weeks after Baseline)
Perceived Stress Scale (PSS) [3-month Follow-up]
Time frame: 3-month Follow-up (3 months after Post-Assessment)
Recognize Subscale of the Mindful Eating Questionnaire (Post-Assessment)
Time frame: Post-Assessment (6 weeks after Baseline)
Recognize Subscale of the Mindful Eating Questionnaire (3-month Follow-up)
Time frame: 3-month Follow-up (3 months after Post-Assessment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24570244Ogden 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.
- Background: PubMed 26478602Lichter 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.
- Background: PubMed 18048787Bates LM, Acevedo-Garcia D, Alegria M, Krieger N. Immigration and generational trends in body mass index and obesity in the United States: results of the National Latino and Asian American Survey, 2002-2003. Am J Public Health. 2008 Jan;98(1):70-7. doi: 10.2105/AJPH.2006.102814. Epub 2007 Nov 29.
- Background: PubMed 9924171Haldeman GA, Croft JB, Giles WH, Rashidee A. Hospitalization of patients with heart failure: National Hospital Discharge Survey, 1985 to 1995. Am Heart J. 1999 Feb;137(2):352-60. doi: 10.1053/hj.1999.v137.95495.
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- Individual participant dataSharing planned: No
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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.
Marilyn Stern, PhD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADAPT+ and EUC in people with Pediatric Obesity, run by University of South Florida 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 17 Apr 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?
Yes. Results are posted in the registry (first posted 17 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Acceptability (time frame: 6 weeks after baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04800432, which also lists 96 linked publications.
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 17 Apr 2024.