ObesityPAACNCT01197443
Parents as the Agent of Change for Childhood Obesity
A study testing Parent-only Group and Parent + Child Group in people with Obesity, run by University of California, San Diego at 1 site in United States.
Trial summary
The overall intent of this study is to explore a promising mode for delivering treatment for childhood obesity via parent education only, and to evaluate the cost effectiveness compared to the current gold standard treatment of parent-and-child dual education. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Parent-only Group and Parent + Child Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Overweight child 8-12 years of age and above the 95th% for age and gender
- An overweight (BMI > 25) parent willing to participate and attend all treatment meetings
- Eligible parent who can read at a minimum of an 8th grade level
- Family willing to commit to 5 months of treatment attendance, and follow-up for 18 months post-treatment.
Who cannot join
- Major child psychiatric disorder diagnoses
- Child diagnoses of a serious current physical disease (such as diabetes) for which physician supervision of diet and exercise prescription are needed (self-report)
- Family with restrictions on types of food, such as food allergies, religious, or ethnic practices that limit the foods available in the home
- Child with physical difficulties that limit the ability to exercise
- Child with an active eating disorder (based on EDE interview)
- Families where children or parents are involved in swimming or weight training more than 5 hours per week
- Major parent psychiatric disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Center for Healthy Eating and Activity Research (CHEAR)
La Jolla, California, 92093
About this study
The overall intent of this study is to explore a promising mode for delivering treatment for childhood obesity via parent education only, and to evaluate the cost effectiveness compared to the current gold standard treatment of parent-and-child dual education.
Read the detailed description
This study is a randomized clinical trial in which 150 overweight 8-12 year old children and their parent will be randomly assigned by the gender of the child to one of two conditions; a parent-only intervention or a parent + child intervention. Both treatment arms will provide behavioral treatment for childhood obesity for 5 months, and participants will be followed for 18-months post-treatment. Assessments will occur at baseline, immediately post-treatment, 6-12- and 18-months post-treatment. The overall intent of this study is to explore a promising mode for delivering treatment for childhood obesity (parent-only), and to evaluate the cost effectiveness compared to the current gold standard treatment of parent + child. Results of these studies will be utilized as evidence to recommend changes in the standard treatment for childhood obesity. This program of research is critical for exploring and developing interventions that mobilize parents to intervene with their overweight and obese children. The timing of this research is optimal given the increase in childhood obesity in the United States, and the need for disseminative intervention and prevention programs.
- Conditions
- Obesity
- Being tested
- Parent-only Group, Parent + Child Group
- Keywords
- obesity, overweight, overweight children, overweight parents, families with overweight child, body mass index, BMI, weight, childhood obesity, diet, treatment, parent modeling, traffic light diet, stop light diet
- Medical subject headings
- Obesity, Overweight, Body Weight, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-only GroupBehavioural
Also called Parents as the Agent of Change for Childhood Obesity (PAAC)
Parent-only group will include the same skills and techniques to promote weight loss as given to the parent + child group, but the information will be delivered only to the parent. Parent group will be compared to the parent group of the parent + child treatment arm. The focus will be on implementing skills learned to assist the child in weight management. The treatment length is set for 12 weekly meetings and bi-monthly meetings during months 4 and 5. Each group session will be 60-min including weigh-ins. Group meetings focus on behavior change, weight loss, healthy eating and activity for the overweight child and parent.
Parent + Child GroupBehavioural
Also called Parents as the Agent of Change for Childhood Obesity (PAAC)
The treatment for participants in the parent + child group will be administered in two separate groups, one for the parents and one for the child. Treatment will include the same skills and techniques to promote weight loss as given to the parent-only group, but the information will be delivered to both the parent and child. The treatment length, session schedule, treatment content and follow-up assessments are same as the parent-only group.
| Study group | Role | What they receive |
|---|---|---|
| Parent-only Group | Experimental | Treatment will be administered to parents of the overweight child. Parent-only group treatment will include all of the same skills and techniques to promote weight loss, but the information will be delivered only to the parent. Participation of the children assigned to the parent-only treatment arm will be limited to the baseline and follow-up assessments. Receives: Behavioral: Parent-only Group |
| Parent + child Group | Active comparator | The treatment for participants in the parent + child arm will be administered in two separate groups, one for the parents and one for the child. Receives: Behavioral: Parent + Child Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child
The primary hypothesis is that the parent-only treatment will produce a decrease in the target child's weight (BMI for age percentile/BMI_Z) that is not inferior to the parent + child treatment immediately following treatment.
Measured: At post-treatment visit (after 6-month treatment)
To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child
The primary hypothesis is that the parent-only treatment will produce a decrease in the target child's weight (BMI for age percentile/BMI_Z) that is not inferior to the parent + child treatment at post-treatment 6-month follow-up visit.
Measured: At post-treatment 6-month follow-up visit
To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child
The primary hypothesis is that the parent-only treatment will produce a decrease in the target child's weight (BMI for age percentile/BMI_Z) that is not inferior to the parent + child treatment at post-treatment 18-month follow-up visit.
Measured: At post-treatment 18-month follow-up visit
Secondary outcomes (38)
To evaluate the cost-effectiveness of parent-only treatment versus parent + child treatment
We predict that the parent-only treatment will be more cost-effective than the parent + child group, as measured by calculating cost effectiveness ratios from both third party payer and limited societal perspectives at post-treatment visit (after 5-month treatment).
Measured: At post-treatment visit (after 6-month treatment)
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's dietary quality
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's dietary quality that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaire measures specific for child and parent.
Measured: At post-treatment (after 6-month treatment)
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's exercise behavior
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's exercise behavior that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.
Measured: At post-treatment visit (after 6-month treatment)
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's quality of life
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's quality of life consisting of physical comfort, body esteem, social life, and family relations that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.
Measured: At post-treatment visit (after 6-month treatment)
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's psychosocial measures
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's psychosocial measures, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.
Measured: At post-treatment visit (after 6-month treatment)
To compare effect of parent-only treatment versus parent + child treatment on parent's adherence
We hypothesize that the parent-only treatment will produce an effect on the parent's adherence that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by group attendance and adherence to behavior recommendations.
Measured: At post-treatment visit (after 6-month treatment)
To compare effect of parent-only treatment versus parent + child treatment on parenting style
We hypothesize that the parent-only treatment will produce an effect on the parenting style that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.
Measured: At post-treatment visit (after 6-month treatment)
To compare effect of parent-only treatment versus parent + child treatment on parent's weight loss
We hypothesize that the parent-only treatment will produce parent weight loss (as measured by BMI) that is not inferior to the parent + child treatment.
Measured: At post-treatment visit (after 6-month treatment)
To evaluate the predictors of success in childhood obesity treatments by evaluating change in target child's and parent's weight
A decrease in BMI percentile for age for target child and a decrease in BMI for parent will be evaluated.
Measured: At post-treatment visit (after 6-month treatment)
To evaluate the predictors of success in childhood obesity treatments by evaluating compliance
Compliance will be measured by group attendance and adherence to behavior recommendations.
Measured: At post-treatment visit (after 6-month treatment)
To evaluate the predictors of success in childhood obesity treatments by evaluating changes in household food environment
Changes in household food environment will be evaluated by assessing questionnaires specific for household food environment (Food Shelf Inventory).
Measured: At post-treatment visit (after 6-month treatment)
To evaluate the predictors of success in childhood obesity treatment by evaluating change in parenting style
Changes in parenting style will be evaluated by assessing questionnaires that are specific to parenting style for child and parent.
Measured: At post-treatment visit (after 6-month treatment)
To evaluate the predictors of success in childhood obesity treatment by evaluating changes in target child's and parent's psychosocial functioning
Changes in the target child's and parent's psychosocial functioning will be evaluated by assessing questionnaire measures specific to child and parent psychosocial functioning.
Measured: At post-treatment visit (after 6-month treatment)
To evaluate the cost-effectiveness of parent-only treatment versus parent + child treatment
We predict that the parent-only treatment will be more cost-effective than the parent + child group, as measured by calculating cost effectiveness ratios from both third party payer and limited societal perspectives at post-treatment 6-month follow-up visit.
Measured: At post-treatment 6-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's dietary quality
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's dietary quality that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaire measures specific for child and parent.
Measured: At post-treatment 6-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's dietary quality
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's dietary quality that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaire measures specific for child and parent.
Measured: At post-treatment 18-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's exercise behavior
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's exercise behavior that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.
Measured: At post-treatment 6-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's exercise behavior
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's exercise behavior that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.
Measured: At post-treatment 18-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's quality of life
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's quality of life consisting of physical comfort, body esteem, social life, and family relations that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.
Measured: At post-treatment 6-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's quality of life
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's quality of life consisting of physical comfort, body esteem, social life, and family relations that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.
Measured: At post-treatment 18-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's psychosocial measures
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's psychosocial measures, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.
Measured: At post-treatment 6-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's psychosocial measures
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's psychosocial measures, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.
Measured: A post-treatment 18-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on parent's adherence
We hypothesize that the parent-only treatment will produce an effect on the parent's adherence that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by group attendance and adherence to behavior recommendations.
Measured: At post-treatment 6-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on parent's adherence
We hypothesize that the parent-only treatment will produce an effect on the parent's adherence that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by group attendance and adherence to behavior recommendations.
Measured: At post-treatment 18-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on parenting style
We hypothesize that the parent-only treatment will produce an effect on the parenting style that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.
Measured: At post-treatment 6-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on parenting style
We hypothesize that the parent-only treatment will produce an effect on the parenting style that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.
Measured: At post-treatment 18-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on parent's weight loss
We hypothesize that the parent-only treatment will produce parent weight loss (as measured by BMI) that is not inferior to the parent + child treatment.
Measured: At post-treatment 6-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on parent's weight loss
We hypothesize that the parent-only treatment will produce parent weight loss (as measured by BMI) that is not inferior to the parent + child treatment.
Measured: At post-treatment 18-month follow-up visit
To evaluate the predictors of success in childhood obesity treatments by evaluating change in target child's and parent's weight
A decrease in BMI percentile for age for target child and a decrease in BMI for parent will be evaluated.
Measured: At post-treatment 6-month follow-up visit
To evaluate the predictors of success in childhood obesity treatments by evaluating change in target child's and parent's weight
A decrease in BMI percentile for age for target child and a decrease in BMI for parent will be evaluated.
Measured: At post-treatment 18-month follow-up visit
To evaluate the predictors of success in childhood obesity treatments by evaluating compliance
Compliance will be measured by group attendance and adherence to behavior recommendations.
Measured: At post-treatment 6-month follow-up visit
To evaluate the predictors of success in childhood obesity treatments by evaluating compliance
Compliance will be measured by group attendance and adherence to behavior recommendations.
Measured: At post-treatment 18-month follow-up visit
To evaluate the predictors of success in childhood obesity treatments by evaluating changes in household food environment
Changes in household food environment will be evaluated by assessing questionnaires specific for household food environment (Food Shelf Inventory).
Measured: At post-treatment 6-month follow-up visit
To evaluate the predictors of success in childhood obesity treatments by evaluating changes in household food environment
Changes in household food environment will be evaluated by assessing questionnaires specific for household food environment (Food Shelf Inventory).
Measured: At post-treatment 18-month follow-up visit
To evaluate the predictors of success in childhood obesity treatment by evaluating change in parenting style
Changes in parenting style will be evaluated by assessing questionnaires that are specific to parenting style for child and parent.
Measured: At post-treatment 6-month follow-up visit
To evaluate the predictors of success in childhood obesity treatment by evaluating change in parenting style
Changes in parenting style will be evaluated by assessing questionnaires that are specific to parenting style for child and parent.
Measured: At post-treatment 18-month follow-up visit
To evaluate the predictors of success in childhood obesity treatment by evaluating changes in target child's and parent's psychosocial functioning
Changes in the target child's and parent's psychosocial functioning will be evaluated by assessing questionnaire measures specific to child and parent psychosocial functioning.
Measured: At post-treatment 6-month follow-up visit
To evaluate the predictors of success in childhood obesity treatment by evaluating changes in target child's and parent's psychosocial functioning
Changes in the target child's and parent's psychosocial functioning will be evaluated by assessing questionnaire measures specific to child and parent psychosocial functioning.
Measured: At post-treatment 18-month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerri Boutelle, University of California, San Diego
- Investigators
- Kerri Boutelle, PhD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197443
- Sponsor's protocol ID
- 071669
- Acronym
- PAAC
- Status last verified
- Nov 2015
- First submitted
- 17 Aug 2010
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bauer KW, Nelson MC, Boutelle KN, Neumark-Sztainer D. Parental influences on adolescents' physical activity and sedentary behavior: longitudinal findings from Project EAT-II. Int J Behav Nutr Phys Act. 2008 Feb 26;5:12. doi: 10.1186/1479-5868-5-12.
PubMed 18302765Epstein LH. Family-based behavioural intervention for obese children. Int J Obes Relat Metab Disord. 1996 Feb;20 Suppl 1:S14-21.
PubMed 8646260Epstein LH, Wing RR, Steranchak L, Dickson B, Michelson J. Comparison of family-based behavior modification and nutrition education for childhood obesity. J Pediatr Psychol. 1980 Mar;5(1):25-36. doi: 10.1093/jpepsy/5.1.25. No abstract available.
PubMed 7452420Epstein LH, Valoski A, Wing RR, McCurley J. Ten-year follow-up of behavioral, family-based treatment for obese children. JAMA. 1990 Nov 21;264(19):2519-23.
PubMed 2232019Wang G, Dietz WH. Economic burden of obesity in youths aged 6 to 17 years: 1979-1999. Pediatrics. 2002 May;109(5):E81-1. doi: 10.1542/peds.109.5.e81.
PubMed 11986487Birch LL, Davison KK. Family environmental factors influencing the developing behavioral controls of food intake and childhood overweight. Pediatr Clin North Am. 2001 Aug;48(4):893-907. doi: 10.1016/s0031-3955(05)70347-3.
PubMed 11494642Faith MS, Scanlon KS, Birch LL, Francis LA, Sherry B. Parent-child feeding strategies and their relationships to child eating and weight status. Obes Res. 2004 Nov;12(11):1711-22. doi: 10.1038/oby.2004.212.
PubMed 15601964Clark HR, Goyder E, Bissell P, Blank L, Peters J. How do parents' child-feeding behaviours influence child weight? Implications for childhood obesity policy. J Public Health (Oxf). 2007 Jun;29(2):132-41. doi: 10.1093/pubmed/fdm012. Epub 2007 Apr 18.
PubMed 17442696Boutelle KN, Kang Sim DE, Eichen DM, Manzano MA, Rhee KE, Strong DR. Predictors of parent self-monitoring patterns in a family-based behavioral weight loss treatment program. Int J Obes (Lond). 2024 Oct;48(10):1457-1464. doi: 10.1038/s41366-024-01574-8. Epub 2024 Jul 15.
PubMed 39009764Kang Sim DE, Strong DR, Manzano MA, Rhee KE, Boutelle KN. Evaluation of dyadic changes of parent-child weight loss patterns during a family-based behavioral treatment for obesity. Pediatr Obes. 2020 Jun;15(6):e12622. doi: 10.1111/ijpo.12622. Epub 2020 Feb 12.
PubMed 32048808Eichen DM, Strong DR, Rhee KE, Rock CL, Crow SJ, Epstein LH, Wilfley DE, Boutelle KN. Change in eating disorder symptoms following pediatric obesity treatment. Int J Eat Disord. 2019 Mar;52(3):299-303. doi: 10.1002/eat.23015. Epub 2019 Jan 14.
PubMed 30638271Boutelle KN, Rhee KE, Liang J, Braden A, Douglas J, Strong D, Rock CL, Wilfley DE, Epstein LH, Crow SJ. Effect of Attendance of the Child on Body Weight, Energy Intake, and Physical Activity in Childhood Obesity Treatment: A Randomized Clinical Trial. JAMA Pediatr. 2017 Jul 1;171(7):622-628. doi: 10.1001/jamapediatrics.2017.0651.
PubMed 28558104
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents as the Agent of Change for Childhood Obesity
- ClinicalTrials.gov ID
- NCT01197443
- Acronym / sponsor ID
- PAAC / 071669
- Conditions
- Obesity
- Keywords
- obesity, overweight, overweight children, overweight parents, families with overweight child, body mass index, BMI, weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall intent of this study is to explore a promising mode for delivering treatment for childhood obesity via parent education only, and to evaluate the cost effectiveness compared to the current gold standard treatment of parent-and-child dual education.
Detailed description
This study is a randomized clinical trial in which 150 overweight 8-12 year old children and their parent will be randomly assigned by the gender of the child to one of two conditions; a parent-only intervention or a parent + child intervention. Both treatment arms will provide behavioral treatment for childhood obesity for 5 months, and participants will be followed for 18-months post-treatment. Assessments will occur at baseline, immediately post-treatment, 6-12- and 18-months post-treatment. The overall intent of this study is to explore a promising mode for delivering treatment for childhood obesity (parent-only), and to evaluate the cost effectiveness compared to the current gold standard treatment of parent + child. Results of these studies will be utilized as evidence to recommend changes in the standard treatment for childhood obesity. This program of research is critical for exploring and developing interventions that mobilize parents to intervene with their overweight and obese children. The timing of this research is optimal given the increase in childhood obesity in the United States, and the need for disseminative intervention and prevention programs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent-only Group | Experimental | Behavioral: Parent-only GroupTreatment will be administered to parents of the overweight child. Parent-only group treatment will include all of the same skills and techniques to promote weight loss, but the information will be delivered only to the parent. Participation of the children assigned to the parent-only treatment arm will be limited to the baseline and follow-up assessments. |
| Parent + child Group | Active comparator | Behavioral: Parent + Child GroupThe treatment for participants in the parent + child arm will be administered in two separate groups, one for the parents and one for the child. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Overweight child 8-12 years of age and above the 95th% for age and gender
- An overweight (BMI > 25) parent willing to participate and attend all treatment meetings
- Eligible parent who can read at a minimum of an 8th grade level
- Family willing to commit to 5 months of treatment attendance, and follow-up for 18 months post-treatment.
Key exclusion criteria (7 listed)
- Major child psychiatric disorder diagnoses
- Child diagnoses of a serious current physical disease (such as diabetes) for which physician supervision of diet and exercise prescription are needed (self-report)
- Family with restrictions on types of food, such as food allergies, religious, or ethnic practices that limit the foods available in the home
- Child with physical difficulties that limit the ability to exercise
- Child with an active eating disorder (based on EDE interview)
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 |
|---|---|---|
| Parent-only GroupAlso: Parents as the Agent of Change for Childhood Obesity (PAAC)Parent-only group will include the same skills and techniques to promote weight loss as given to the parent + child group, but the information will be delivered only to the parent. Parent group will be compared to the parent group of the parent + child treatment arm. The focus will be on implementing skills learned to assist the child in weight management. The treatment length is set for 12 weekly meetings and bi-monthly meetings during months 4 and 5. Each group session will be 60-min including weigh-ins. Group meetings focus on behavior change, weight loss, healthy eating and activity for the overweight child and parent. | Behavioural | Parent-only Group |
| Parent + Child GroupAlso: Parents as the Agent of Change for Childhood Obesity (PAAC)The treatment for participants in the parent + child group will be administered in two separate groups, one for the parents and one for the child. Treatment will include the same skills and techniques to promote weight loss as given to the parent-only group, but the information will be delivered to both the parent and child. The treatment length, session schedule, treatment content and follow-up assessments are same as the parent-only group. | Behavioural | Parent + child Group |
Primary outcome
To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child
Time frame: At post-treatment visit (after 6-month treatment)
The primary hypothesis is that the parent-only treatment will produce a decrease in the target child's weight (BMI for age percentile/BMI_Z) that is not inferior to the parent + child treatment immediately following treatment.
To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child
Time frame: At post-treatment 6-month follow-up visit
The primary hypothesis is that the parent-only treatment will produce a decrease in the target child's weight (BMI for age percentile/BMI_Z) that is not inferior to the parent + child treatment at post-treatment 6-month follow-up visit.
To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child
Time frame: At post-treatment 18-month follow-up visit
The primary hypothesis is that the parent-only treatment will produce a decrease in the target child's weight (BMI for age percentile/BMI_Z) that is not inferior to the parent + child treatment at post-treatment 18-month follow-up visit.
38 secondary outcomes
To evaluate the cost-effectiveness of parent-only treatment versus parent + child treatment
Time frame: At post-treatment visit (after 6-month treatment)
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's dietary quality
Time frame: At post-treatment (after 6-month treatment)
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's exercise behavior
Time frame: At post-treatment visit (after 6-month treatment)
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's quality of life
Time frame: At post-treatment visit (after 6-month treatment)
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's psychosocial measures
Time frame: At post-treatment visit (after 6-month treatment)
To compare effect of parent-only treatment versus parent + child treatment on parent's adherence
Time frame: At post-treatment visit (after 6-month treatment)
To compare effect of parent-only treatment versus parent + child treatment on parenting style
Time frame: At post-treatment visit (after 6-month treatment)
To compare effect of parent-only treatment versus parent + child treatment on parent's weight loss
Time frame: At post-treatment visit (after 6-month treatment)
To evaluate the predictors of success in childhood obesity treatments by evaluating change in target child's and parent's weight
Time frame: At post-treatment visit (after 6-month treatment)
To evaluate the predictors of success in childhood obesity treatments by evaluating compliance
Time frame: At post-treatment visit (after 6-month treatment)
To evaluate the predictors of success in childhood obesity treatments by evaluating changes in household food environment
Time frame: At post-treatment visit (after 6-month treatment)
To evaluate the predictors of success in childhood obesity treatment by evaluating change in parenting style
Time frame: At post-treatment visit (after 6-month treatment)
To evaluate the predictors of success in childhood obesity treatment by evaluating changes in target child's and parent's psychosocial functioning
Time frame: At post-treatment visit (after 6-month treatment)
To evaluate the cost-effectiveness of parent-only treatment versus parent + child treatment
Time frame: At post-treatment 6-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's dietary quality
Time frame: At post-treatment 6-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's dietary quality
Time frame: At post-treatment 18-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's exercise behavior
Time frame: At post-treatment 6-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's exercise behavior
Time frame: At post-treatment 18-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's quality of life
Time frame: At post-treatment 6-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's quality of life
Time frame: At post-treatment 18-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's psychosocial measures
Time frame: At post-treatment 6-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's psychosocial measures
Time frame: A post-treatment 18-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on parent's adherence
Time frame: At post-treatment 6-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on parent's adherence
Time frame: At post-treatment 18-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on parenting style
Time frame: At post-treatment 6-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on parenting style
Time frame: At post-treatment 18-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on parent's weight loss
Time frame: At post-treatment 6-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on parent's weight loss
Time frame: At post-treatment 18-month follow-up visit
To evaluate the predictors of success in childhood obesity treatments by evaluating change in target child's and parent's weight
Time frame: At post-treatment 6-month follow-up visit
To evaluate the predictors of success in childhood obesity treatments by evaluating change in target child's and parent's weight
Time frame: At post-treatment 18-month follow-up visit
To evaluate the predictors of success in childhood obesity treatments by evaluating compliance
Time frame: At post-treatment 6-month follow-up visit
To evaluate the predictors of success in childhood obesity treatments by evaluating compliance
Time frame: At post-treatment 18-month follow-up visit
To evaluate the predictors of success in childhood obesity treatments by evaluating changes in household food environment
Time frame: At post-treatment 6-month follow-up visit
To evaluate the predictors of success in childhood obesity treatments by evaluating changes in household food environment
Time frame: At post-treatment 18-month follow-up visit
To evaluate the predictors of success in childhood obesity treatment by evaluating change in parenting style
Time frame: At post-treatment 6-month follow-up visit
To evaluate the predictors of success in childhood obesity treatment by evaluating change in parenting style
Time frame: At post-treatment 18-month follow-up visit
To evaluate the predictors of success in childhood obesity treatment by evaluating changes in target child's and parent's psychosocial functioning
Time frame: At post-treatment 6-month follow-up visit
To evaluate the predictors of success in childhood obesity treatment by evaluating changes in target child's and parent's psychosocial functioning
Time frame: At post-treatment 18-month follow-up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Background: PubMed 18302765Bauer KW, Nelson MC, Boutelle KN, Neumark-Sztainer D. Parental influences on adolescents' physical activity and sedentary behavior: longitudinal findings from Project EAT-II. Int J Behav Nutr Phys Act. 2008 Feb 26;5:12. doi: 10.1186/1479-5868-5-12.
- Background: PubMed 8646260Epstein LH. Family-based behavioural intervention for obese children. Int J Obes Relat Metab Disord. 1996 Feb;20 Suppl 1:S14-21.
- Background: PubMed 7452420Epstein LH, Wing RR, Steranchak L, Dickson B, Michelson J. Comparison of family-based behavior modification and nutrition education for childhood obesity. J Pediatr Psychol. 1980 Mar;5(1):25-36. doi: 10.1093/jpepsy/5.1.25. No abstract available.
- Background: PubMed 2232019Epstein LH, Valoski A, Wing RR, McCurley J. Ten-year follow-up of behavioral, family-based treatment for obese children. JAMA. 1990 Nov 21;264(19):2519-23.
- Background: PubMed 11986487Wang G, Dietz WH. Economic burden of obesity in youths aged 6 to 17 years: 1979-1999. Pediatrics. 2002 May;109(5):E81-1. doi: 10.1542/peds.109.5.e81.
- Background: PubMed 11494642Birch LL, Davison KK. Family environmental factors influencing the developing behavioral controls of food intake and childhood overweight. Pediatr Clin North Am. 2001 Aug;48(4):893-907. doi: 10.1016/s0031-3955(05)70347-3.
- Background: PubMed 15601964Faith MS, Scanlon KS, Birch LL, Francis LA, Sherry B. Parent-child feeding strategies and their relationships to child eating and weight status. Obes Res. 2004 Nov;12(11):1711-22. doi: 10.1038/oby.2004.212.
- Background: PubMed 17442696Clark HR, Goyder E, Bissell P, Blank L, Peters J. How do parents' child-feeding behaviours influence child weight? Implications for childhood obesity policy. J Public Health (Oxf). 2007 Jun;29(2):132-41. doi: 10.1093/pubmed/fdm012. Epub 2007 Apr 18.
- Derived from this study: PubMed 39009764Boutelle KN, Kang Sim DE, Eichen DM, Manzano MA, Rhee KE, Strong DR. Predictors of parent self-monitoring patterns in a family-based behavioral weight loss treatment program. Int J Obes (Lond). 2024 Oct;48(10):1457-1464. doi: 10.1038/s41366-024-01574-8. Epub 2024 Jul 15.
- Derived from this study: PubMed 32048808Kang Sim DE, Strong DR, Manzano MA, Rhee KE, Boutelle KN. Evaluation of dyadic changes of parent-child weight loss patterns during a family-based behavioral treatment for obesity. Pediatr Obes. 2020 Jun;15(6):e12622. doi: 10.1111/ijpo.12622. Epub 2020 Feb 12.
- Derived from this study: PubMed 30638271Eichen DM, Strong DR, Rhee KE, Rock CL, Crow SJ, Epstein LH, Wilfley DE, Boutelle KN. Change in eating disorder symptoms following pediatric obesity treatment. Int J Eat Disord. 2019 Mar;52(3):299-303. doi: 10.1002/eat.23015. Epub 2019 Jan 14.
- Derived from this study: PubMed 28558104Boutelle KN, Rhee KE, Liang J, Braden A, Douglas J, Strong D, Rock CL, Wilfley DE, Epstein LH, Crow SJ. Effect of Attendance of the Child on Body Weight, Energy Intake, and Physical Activity in Childhood Obesity Treatment: A Randomized Clinical Trial. JAMA Pediatr. 2017 Jul 1;171(7):622-628. doi: 10.1001/jamapediatrics.2017.0651.
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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.
Kerri Boutelle, PhD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-only Group and Parent + Child Group in people with Obesity, run by University of California, San Diego 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 4 inclusion and 7 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 2 Dec 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child (time frame: At post-treatment visit (after 6-month treatment)). The study lists 3 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 NCT01197443, which also lists 12 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 2 Dec 2015.