Obesity
Conditions
Keywords
obesity, guided self help treatment, treatment method, overweight, overweight children and parents, families with overweight child, efficacy, body mass index, weight
Brief summary
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.
Detailed description
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.
Interventions
The immediate treatment group starts the 5-month treatment right after baseline assessment.
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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* child between the ages of 8 & 12 * an moderately overweight child with a BMI% between 85-97% * child has a parent willing to participate * child has a parent who can read English at a minimum of a 6th grade level * family who is willing to commit to treatment attendance and attendance at all assessments.
Exclusion criteria
* Child psychiatric disorder diagnoses (based on parent report) * Child diagnoses of a serious current physical disease (such as diabetes) * Child who is taking medications that may impact their weight * Child with physical difficulties that limit the ability to exercise * Child with an active eating disorder * Child and parent will be moving out of the San Diego County before study completion * Child and/or parent has a modified diet due to religious or socially conscious reasons (such as Vegan, vegetarian)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Child BMI | 5 months |
Secondary
| Measure | Time frame |
|---|---|
| Parent BMI | 5 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Immediate Treatment Group The immediate treatment group begins the 5-month treatment immediately after baseline assessment. | 25 |
| Delayed Treatment Group The delayed treatment group serves as the control group. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Immediate Treatment Group | Delayed Treatment Group | Total |
|---|---|---|---|
| Age, Continuous | 10.3 years STANDARD_DEVIATION 1.3 | 10.5 years STANDARD_DEVIATION 1.4 | 10.4 years STANDARD_DEVIATION 1.35 |
| Child BMI | 24.1 kg/m^2 STANDARD_DEVIATION 1.9 | 24.4 kg/m^2 STANDARD_DEVIATION 2.6 | 24.2 kg/m^2 STANDARD_DEVIATION 2.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 21 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Parent BMI | 27.5 kg/m^2 STANDARD_DEVIATION 6.1 | 27.9 kg/m^2 STANDARD_DEVIATION 6.1 | 27.7 kg/m^2 STANDARD_DEVIATION 6.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 21 Participants | 42 Participants |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male Male | 10 Participants | 9 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Child BMI
Time frame: 5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Child BMI | 23.3 kg/m^2 | Standard Deviation 2.1 |
| Delayed Treatment Group | Child BMI | 25.17 kg/m^2 | Standard Deviation 2.79 |
Secondary
Parent BMI
Time frame: 5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Treatment Group | Parent BMI | 26.8 kg/m^2 | Standard Deviation 6.4 |
| Delayed Treatment Group | Parent BMI | 28.0 kg/m^2 | Standard Deviation 6.2 |