Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DK080266-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate whether a home based program can teach parents and moderately overweight kids who are of 8-12 years old with a BMI% between 85-97%, how to manage their child's weight. The study uses manuals and involves a short visit to the clinic every other week.
An estimated 4-5 million children between the ages of 6-17 in the United States are obese. Children who are obese are at an increased risk for many negative health consequences in childhood and in adulthood. In addition, these children are at an increased risk for psychosocial consequences in childhood and adolescence, including poor self-esteem, teasing, verbal abuse and social isolation. Guided self-help offers an opportunity to provide empirically based programs to a larger amount of the target population. Once such treatment methods are available, it is possible that the guided self-help treatment for childhood obesity can be disseminated to primary care practitioners, psychologists, nurses, and health educators. Ultimately, the goal of this application is to develop a treatment protocol that can be used by clinics and lay health professionals to intervene with children who are overweight and their parents.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate treatment group | Active Comparator | The immediate treatment group begins the 5-month treatment immediately after baseline assessment. |
|
| Delayed Treatment Group | Other | The delayed treatment group serves as the control group. This group starts treatment 5 months after the baseline assessment. No intervention is involved during this 5-month waiting period. After 5 months, the delayed group is assessed for the second time and then begins the 5-month treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate Treatment Group | Other | The immediate treatment group starts the 5-month treatment right after baseline assessment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Child BMI | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Parent BMI | 5 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kerri Boutelle, PhD | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Center for Obesity and Health//Pediatrics Department | La Jolla | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7287977 | Result | Epstein LH, Wing RR, Koeske R, Andrasik F, Ossip DJ. Child and parent weight loss in family-based behavior modification programs. J Consult Clin Psychol. 1981 Oct;49(5):674-85. doi: 10.1037//0022-006x.49.5.674. No abstract available. | |
| 10619533 | Result | Epstein LH, Kilanowski CK, Consalvi AR, Paluch RA. Reinforcing value of physical activity as a determinant of child activity level. Health Psychol. 1999 Nov;18(6):599-603. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Treatment Group | The immediate treatment group begins the 5-month treatment immediately after baseline assessment. |
| FG001 | Delayed Treatment Group | The delayed treatment group serves as the control group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Treatment Group | The immediate treatment group begins the 5-month treatment immediately after baseline assessment. |
| BG001 | Delayed Treatment Group | The delayed treatment group serves as the control group. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Child BMI | Posted | Mean | Standard Deviation | kg/m^2 | 5 months |
|
|
5 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Treatment Group | The immediate treatment group begins the 5-month treatment immediately after baseline assessment. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kerri Boutelle, Principal Investigator | University of CA, San Diego Center for Healthy Eating and Activity Research | 858-534-8037 | kboutelle@ucsd.edu |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Delayed Treatment Group | Other | The delayed treatment group does not start treatment immediately after the baseline assessment. This group serves as the control group, by not receiving any treatment for 5 months. After the 5 months, the delayed group participants are asked to come in for a second assessment that involves completion of surveys and measurement of height, weight, and physical activity level. After this assessment is completed, the delayed group participants can begin the 5-month treatment. |
|
|
| 12224662 | Result | Epstein LH, Myers MD, Raynor HA, Saelens BE. Treatment of pediatric obesity. Pediatrics. 1998 Mar;101(3 Pt 2):554-70. |
| 11746298 | Result | Peterson CB, Mitchell JE, Engbloom S, Nugent S, Pederson Mussell M, Crow SJ, Thuras P. Self-help versus therapist-led group cognitive-behavioral treatment of binge eating disorder at follow-up. Int J Eat Disord. 2001 Dec;30(4):363-74. doi: 10.1002/eat.1098. |
| 8646260 | Result | Epstein LH. Family-based behavioural intervention for obese children. Int J Obes Relat Metab Disord. 1996 Feb;20 Suppl 1:S14-21. |
| 25181608 | Derived | Accurso EC, Norman GJ, Crow SJ, Rock CL, Boutelle KN. The role of motivation in family-based guided self-help treatment for pediatric obesity. Child Obes. 2014 Oct;10(5):392-9. doi: 10.1089/chi.2014.0023. Epub 2014 Sep 2. |
| 23545372 | Derived | Boutelle KN, Norman GJ, Rock CL, Rhee KE, Crow SJ. Guided self-help for the treatment of pediatric obesity. Pediatrics. 2013 May;131(5):e1435-42. doi: 10.1542/peds.2012-2204. Epub 2013 Apr 1. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Child BMI | Mean | Standard Deviation | kg/m^2 |
|
| Parent BMI | Mean | Standard Deviation | kg/m^2 |
|
|
| Secondary | Parent BMI | Posted | Mean | Standard Deviation | kg/m^2 | 5 months |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Delayed Treatment Group | The delayed treatment group serves as the control group. | 0 | 25 | 0 | 25 | 0 | 25 |
Not provided
Not provided
| D013568 | Pathological Conditions, Signs and Symptoms |