Pediatric Obesity
Conditions
Keywords
Behavioral intervention, Obesity prevention
Brief summary
The percentage of overweight children between the ages of 6 and 11 has nearly tripled in the last three decades, and rates are even higher among African Americans.Overweight children are at-risk for numerous health problems, thus effective treatments are urgently needed. This study will evaluate an innovative intervention for ethnically diverse parents (NOURISH), which focuses on helping parents role model and teach their children healthy behaviors.
Detailed description
Pediatric overweight is a national public health concern. The percentage of overweight children in the U.S. between the ages of 6 and 11 has nearly tripled in the last 3 decades. African American children are particularly at risk. Pediatric overweight is associated with numerous physical and psychological health problems. Moreover, overweight children are at significant risk for obesity in adulthood. Thus, a focus on pediatric overweight is an important step in the prevention of adult obesity. Despite the urgent need for pediatric overweight interventions, outcomes of some of the most rigorous treatments are, at best, mixed. Although research has found that including parents in interventions for pediatric overweight has positive effects on outcomes, parental involvement is usually limited. Moreover, relatively few studies have included sufficient numbers of lower-SES, African American participants, a group at increased risk for pediatric overweight and associated complications. This study will evaluate the efficacy of an intensive intervention targeting ethnically diverse parents of overweight, children ages 6-11 (NOURISH-Nourishing Our Understanding of Role Modeling to Improve Support and Health).
Interventions
BEHAVIORALNOURISH
Participants in the NOURISH intervention will have 6 weekly face-to-face parent group sessions regarding healthy eating and physical activity.
OTHERWellness Group
Participants in the Wellness Group will have one face-to-face group meeting and information regarding healthy eating and physical activity will be provided on a regular basis via mail.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* To qualify for participation, parents/caregivers must have a child between the ages of 6 and 11 with a BMI \> the 85th percentile \[128\]. * This child must also primarily reside in the participating caregiver's home. * Participants also need to speak English fluently, and be able to understand and follow basic instructions and perform simple exercises.
Exclusion criteria
* Caregivers are ineligible if they are: 1. non-ambulatory, 2. pregnant, 3. or have a clinical diagnosis that may be negatively impacted by exercise. * Parents whose children have a medical condition or developmental disorder that precludes weight loss using conventional diet and exercise methods are also ineligible for participation. All parents meeting study criteria will be offered participation in the randomized trial comparing NOURISH with a control group.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child BMI | Basline, Posttest | Children's height and weight were measured and then plotted on the CDC Growth Charts to obtain BMI%ile for age and gender. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child Feeding | Basline, Posttest | The Child Feeding Questionnaire (CFQ) measured parental approaches to and attitudes about feeding their children and the subscale concern about child's weight is reported below in the table. The subscale score was calculated by averaging the items (subscale score range: 3 to 15, higher scores represent greater risk). To compare groups, change scores were calculated by subtracting post-test values from baseline values (negative scores indicate decline in parental concern from baseline to post-test). |
| Child Quality of Life | Basline, Posttest | Pediatric Health-Related Quality of Life (PedsQL4.0) change scores from baseline to posttest We reported the Total Score. The PedsQL4.0 response scale ranges from 0 - 4. The items are reverse-scored for interpretability and higher scores indicate higher quality of life. We used the Total Score, or the mean computed as the sum of all the items over the number of items answered on all the Scales. The current report did not provide subscores. |
| Parental BMI | Baseline, Posttest | Height and weight were measured by trained staff and used to calculate BMI. Change scores of parental BMI from baseline to posttest were calculated to show difference between treatment arms. |
| Parental Dietary Intake of Fat | Baseline, Posttest | Parents completed a 3 day dietary record which was reviewed by a dietitian and analyzed using the Nutrition Data System Software (NDS-R) to calculate parental fat intake. Change scores were calculated by subtracting post-test values from baseline values; thus, a negative score indicates a greater reduction in fat intake at post-testing. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NOURISH Only parents participated in the weekly intervention. Intervention content was grounded in Social Cognitive Theory (SCT); the influence of social learning on behavioral outcomes (e.g., parent's modeling of healthy behavior) was emphasized. Weekly topics included implementing healthy lifestyle behaviors, authoritarian parenting approaches, and strategies for overcoming barriers to change. Parents received pedometers for themselves and 1 of their children. The first 2 waves and second 2 waves of participants received a 12 and 6 week face-to-face intervention (NOURISH), respectively. A one-hour booster session was available for all intervention participants 2 months after completion of the interventions. | 92 |
| Wellness Group Only parents participated in the placebo control group which involved attending a group session moderated by an independent interventionist. This interventionist was blinded to the Specific Aims and hypotheses of this study. The session addressed the role of diet and exercise in pediatric overweight. In addition, control parents received pedometers (and instructions on their use) for themselves and 1 of their children. Finally, control participants were mailed publicly available brochures on pediatric overweight on 2 occasions during the study. Control participants were also sent one additional packet of information (essentially a review of previous mail outs) 2 months after post-testing. | 92 |
| Total | 184 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Baseline to Post-Assessment | Lost to Follow-up | 28 | 29 |
| Baseline to Post-Assessment | Withdrawal by Subject | 5 | 0 |
| Post to 6 Month Follow-up | Lost to Follow-up | 32 | 30 |
Baseline characteristics
| Characteristic | NOURISH | Wellness Group | Total |
|---|---|---|---|
| Age, Continuous Adult Age | 38.80 years STANDARD_DEVIATION 6.71 | 40.32 years STANDARD_DEVIATION 7.81 | 39.90 years STANDARD_DEVIATION 7.4 |
| Age, Continuous Child Age | 8.70 years STANDARD_DEVIATION 1.47 | 8.48 years STANDARD_DEVIATION 1.53 | 8.60 years STANDARD_DEVIATION 1.5 |
| Sex: Female, Male Female | 74 Participants | 73 Participants | 147 Participants |
| Sex: Female, Male Male | 18 Participants | 19 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 92 | 0 / 92 |
| serious Total, serious adverse events | 0 / 92 | 0 / 92 |
Outcome results
Primary
Child BMI
Children's height and weight were measured and then plotted on the CDC Growth Charts to obtain BMI%ile for age and gender.
Time frame: Basline, Posttest
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOURISH | Child BMI | Baseline | 98.47 percentile | Standard Deviation 2.24 |
| NOURISH | Child BMI | Post-test (12 wks -waves 1-2; 6 weeks-waves 3+) | 98.19 percentile | Standard Deviation 2.73 |
| Wellness Group | Child BMI | Baseline | 97.86 percentile | Standard Deviation 2.67 |
| Wellness Group | Child BMI | Post-test (12 wks -waves 1-2; 6 weeks-waves 3+) | 97.86 percentile | Standard Deviation 2.61 |
p-value: 0.008Chi-squared
Secondary
Child Feeding
The Child Feeding Questionnaire (CFQ) measured parental approaches to and attitudes about feeding their children and the subscale concern about child's weight is reported below in the table. The subscale score was calculated by averaging the items (subscale score range: 3 to 15, higher scores represent greater risk). To compare groups, change scores were calculated by subtracting post-test values from baseline values (negative scores indicate decline in parental concern from baseline to post-test).
Time frame: Basline, Posttest
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NOURISH | Child Feeding | -0.16 units on a scale | Standard Deviation 0.44 |
| Wellness Group | Child Feeding | -0.03 units on a scale | Standard Deviation 0.22 |
p-value: 0.041Chi-squared
Secondary
Child Quality of Life
Pediatric Health-Related Quality of Life (PedsQL4.0) change scores from baseline to posttest We reported the Total Score. The PedsQL4.0 response scale ranges from 0 - 4. The items are reverse-scored for interpretability and higher scores indicate higher quality of life. We used the Total Score, or the mean computed as the sum of all the items over the number of items answered on all the Scales. The current report did not provide subscores.
Time frame: Basline, Posttest
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NOURISH | Child Quality of Life | 3.47 units on a scale | Standard Deviation 12.15 |
| Wellness Group | Child Quality of Life | 1.46 units on a scale | Standard Deviation 10.88 |
p-value: 0.61Chi-squared
Secondary
Parental BMI
Height and weight were measured by trained staff and used to calculate BMI. Change scores of parental BMI from baseline to posttest were calculated to show difference between treatment arms.
Time frame: Baseline, Posttest
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NOURISH | Parental BMI | .42 kg/m^2 | Standard Deviation 1.84 |
| Wellness Group | Parental BMI | -.65 kg/m^2 | Standard Deviation 2.96 |
p-value: 0.13Chi-squared
Secondary
Parental Dietary Intake of Fat
Parents completed a 3 day dietary record which was reviewed by a dietitian and analyzed using the Nutrition Data System Software (NDS-R) to calculate parental fat intake. Change scores were calculated by subtracting post-test values from baseline values; thus, a negative score indicates a greater reduction in fat intake at post-testing.
Time frame: Baseline, Posttest
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NOURISH | Parental Dietary Intake of Fat | -6.15 grams | Standard Deviation 13.66 |
| Wellness Group | Parental Dietary Intake of Fat | -0.42 grams | Standard Deviation 15.35 |
p-value: 0.024Chi-squared