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Completed

NCT Number: NCT01197443

Parents as the Agent of Change for Childhood Obesity

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.

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Key information

Conditions

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

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSD Center for Healthy Eating and Activity Research (CHEAR)

La Jolla, California, 92093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Parent-only Group

Behavioral

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.

Other names: Parents as the Agent of Change for Childhood Obesity (PAAC)

Parent + Child Group

Behavioral

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.

Other names: Parents as the Agent of Change for Childhood Obesity (PAAC)

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. To evaluate the cost-effectiveness of parent-only treatment versus parent + child treatment

    Time frame: At post-treatment visit (after 6-month 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).

  2. 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)

    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.

  3. 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)

    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.

  4. 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)

    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.

  5. 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)

    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.

  6. 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)

    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.

  7. To compare effect of parent-only treatment versus parent + child treatment on parenting style

    Time frame: At post-treatment visit (after 6-month treatment)

    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.

  8. 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)

    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.

  9. 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)

    A decrease in BMI percentile for age for target child and a decrease in BMI for parent will be evaluated.

  10. To evaluate the predictors of success in childhood obesity treatments by evaluating compliance

    Time frame: At post-treatment visit (after 6-month treatment)

    Compliance will be measured by group attendance and adherence to behavior recommendations.

  11. 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)

    Changes in household food environment will be evaluated by assessing questionnaires specific for household food environment (Food Shelf Inventory).

  12. 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)

    Changes in parenting style will be evaluated by assessing questionnaires that are specific to parenting style for child and parent.

  13. 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)

    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.

  14. To evaluate the cost-effectiveness of parent-only treatment versus parent + child treatment

    Time frame: At post-treatment 6-month follow-up visit

    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.

  15. 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

    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.

  16. 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

    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.

  17. 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

    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.

  18. 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

    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.

  19. 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

    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.

  20. 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

    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.

  21. 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

    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.

  22. 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

    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.

  23. 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

    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.

  24. 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

    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.

  25. To compare effect of parent-only treatment versus parent + child treatment on parenting style

    Time frame: At post-treatment 6-month follow-up visit

    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.

  26. To compare effect of parent-only treatment versus parent + child treatment on parenting style

    Time frame: At post-treatment 18-month follow-up visit

    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.

  27. 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

    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.

  28. 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

    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.

  29. 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

    A decrease in BMI percentile for age for target child and a decrease in BMI for parent will be evaluated.

  30. 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

    A decrease in BMI percentile for age for target child and a decrease in BMI for parent will be evaluated.

  31. To evaluate the predictors of success in childhood obesity treatments by evaluating compliance

    Time frame: At post-treatment 6-month follow-up visit

    Compliance will be measured by group attendance and adherence to behavior recommendations.

  32. To evaluate the predictors of success in childhood obesity treatments by evaluating compliance

    Time frame: At post-treatment 18-month follow-up visit

    Compliance will be measured by group attendance and adherence to behavior recommendations.

  33. 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

    Changes in household food environment will be evaluated by assessing questionnaires specific for household food environment (Food Shelf Inventory).

  34. 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

    Changes in household food environment will be evaluated by assessing questionnaires specific for household food environment (Food Shelf Inventory).

  35. 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

    Changes in parenting style will be evaluated by assessing questionnaires that are specific to parenting style for child and parent.

  36. 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

    Changes in parenting style will be evaluated by assessing questionnaires that are specific to parenting style for child and parent.

  37. 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

    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.

  38. 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

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Acronym: PAAC

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Sep 9, 2010
Registry last updated
Dec 2, 2015

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

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

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

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