Obesity
Conditions
Brief summary
The goal of this study is to develop and test the efficacy of a scientifically-based, culturally competent seven-session parent directed, obesity prevention program focused on parental feeding strategies that support young children's self-regulation of intake.
Detailed description
The intervention program was developed and piloted. Expected outcomes: At the end of the intervention program, it is expected that parents in the intervention group will: 1) use more child-centered (e.g., repeated presentation of new foods, involvement in food preparation) and less parent-centered feeding directives; 2) be less likely to show an indulgent and more likely to show an authoritative feeding style (feeding responsiveness); 3) show lower scores on restriction and pressure to eat and higher scores on monitoring; and 4) demonstrate higher levels of food knowledge (e.g., best feeding practices, reduced feeding misconceptions). Children in the intervention group are expected to: 1) show more willingness to try new foods, and 2) show increased self-regulation of energy intake. At the end of the interventions, children are expected to show greater consumption of fruits and vegetables (including consuming a wider variety of fruits and vegetables). All effects are expected to continue through the 6- and 12-month follow-ups, although the effects sizes will diminish. Although we do not expect effects on BMI after 6 weeks, we expect to see decreases in children's BMI percentiles by the 6- and 12-month follow-ups for the intervention group-especially for the top 25% of the BMI percentile range. No parental BMI effects are expected.
Interventions
BEHAVIORALParent and child groups focused on self-regulation of eating
Sponsors
Washington State University
University of Colorado, Denver
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
Yes
Inclusion criteria
* Parents whose children attend Head Start with the sample of children equally split on gender and ethnicity, * with representation from ages 3 to 6 years.
Exclusion criteria
* Parents and children who have any kind of food allergies or diabetes or are on special diets will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Children's BMI Percentiles | 12-month follow-up | Measured child height and weight data were collected. Two height and weight measures were averaged for each child. Age- and gender-specific BMI z-scores for each child were calculated. Children were classified into healthy weight (5th to \<85th percentile), overweight (≥85th to \<95th percentile), and obese (≥95th percentile) according to Centers for Disease Control and Prevention standards. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parental Feeding Behaviors | 12-month follow-up | Questionnaire data (parent-report). Subscale scores from the Food Parenting Inventory and Feeding Knowledge Questionnaire were used to measure secondary outcomes. All scales included response categories ranging from 1 to 5. Higher scores were considered better on the following subscales: repeated presentation of new foods; measured child portion sizes; child involvement in food preparation; feeding responsiveness; knowledge of best feeding practices; feeding efficacy. Lower scores were considered better on the subscale of feeding misconceptions. |
Countries
United States
Participant flow
Recruitment details
Parent/child dyads were recruited in 2014-2016 from Head Start centers in Houston, TX, and child care centers serving families with low incomes in Pasco, WA. The Pasco centers were similar to Head Start in that they provided free services and support for families with low incomes. The goal of these centers was to ensure that all children enter kindergarten ready to succeed.
Pre-assignment details
No significant events occurred in this study after participant enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Parent and Child Classes (Prevention Group) Parent and child groups focused on self-regulation of eating | 136 |
| Treatment as Usual (Control Group) Treatment as usual, parents and children did not receive any treatment as the control group. | 119 |
| Total | 255 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12-month Follow-up | Lost to Follow-up | 10 | 3 |
| 6-month Follow-up | Lost to Follow-up | 28 | 17 |
| Group Allocation | Dropped out after randomization, did not attend any lessons, included in analyses as intent-to-treat | 8 | 0 |
| Post Data Collection | Dropped/withdrew from study | 7 | 1 |
| Post Data Collection | Lost to Follow-up | 10 | 23 |
Baseline characteristics
| Characteristic | Treatment as Usual (Control Group) | Parent and Child Classes (Prevention Group) | Total |
|---|---|---|---|
| Age, Continuous | 32.53 years STANDARD_DEVIATION 6.92 | 56.28 months STANDARD_DEVIATION 7.11 | 55.40 months STANDARD_DEVIATION 7.02 |
| Children's BMI Percentiles Healthy weight (<85th percentile) | 79 Participants | 78 Participants | 157 Participants |
| Children's BMI Percentiles Obese (≥95th percentile) | 17 Participants | 29 Participants | 46 Participants |
| Children's BMI Percentiles Overweight (85th to 95th percentile) | 21 Participants | 27 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 119 Participants | 136 Participants | 255 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 119 Parent/child dyad | 136 Parent/child dyad | 225 Parent/child dyad |
| Sex: Female, Male Female | 53 Participants | 136 Participants | 255 Participants |
| Sex: Female, Male Male | 66 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 136 | 0 / 119 |
| other Total, other adverse events | 0 / 136 | 0 / 119 |
| serious Total, serious adverse events | 0 / 136 | 0 / 119 |
Outcome results
Primary
Children's BMI Percentiles
Measured child height and weight data were collected. Two height and weight measures were averaged for each child. Age- and gender-specific BMI z-scores for each child were calculated. Children were classified into healthy weight (5th to \<85th percentile), overweight (≥85th to \<95th percentile), and obese (≥95th percentile) according to Centers for Disease Control and Prevention standards.
Time frame: 12-month follow-up
Population: Prevention group: 76 children assessed at 12-months.~Treatment as usual control group: 71 children assessed at 12-months.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Prevention Group | Children's BMI Percentiles | Healthy weight (<85th percentile) | 49 Participants |
| Prevention Group | Children's BMI Percentiles | Overweight (85th to 95th percentile) | 15 Participants |
| Prevention Group | Children's BMI Percentiles | Obese (≥95th percentile) | 12 Participants |
| Treatment as Usual Control Group | Children's BMI Percentiles | Healthy weight (<85th percentile) | 41 Participants |
| Treatment as Usual Control Group | Children's BMI Percentiles | Overweight (85th to 95th percentile) | 18 Participants |
| Treatment as Usual Control Group | Children's BMI Percentiles | Obese (≥95th percentile) | 12 Participants |
p-value: <0.05Regression, Logistic
Secondary
Parental Feeding Behaviors
Questionnaire data (parent-report). Subscale scores from the Food Parenting Inventory and Feeding Knowledge Questionnaire were used to measure secondary outcomes. All scales included response categories ranging from 1 to 5. Higher scores were considered better on the following subscales: repeated presentation of new foods; measured child portion sizes; child involvement in food preparation; feeding responsiveness; knowledge of best feeding practices; feeding efficacy. Lower scores were considered better on the subscale of feeding misconceptions.
Time frame: 12-month follow-up
Population: Prevention group: 67 parents assessed at 12-months.~Treatment as usual control group: 54 parents assessed at 12-months.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Prevention Group | Parental Feeding Behaviors | feeding responsiveness | 3.8 score on a scale |
| Prevention Group | Parental Feeding Behaviors | knowledge of best feeding practices | 4.1 score on a scale |
| Prevention Group | Parental Feeding Behaviors | measured child portion sizes | 3.1 score on a scale |
| Prevention Group | Parental Feeding Behaviors | feeding misconceptions | 3.0 score on a scale |
| Prevention Group | Parental Feeding Behaviors | repeated presentation of new foods | 3.5 score on a scale |
| Prevention Group | Parental Feeding Behaviors | feeding efficacy | 4.2 score on a scale |
| Prevention Group | Parental Feeding Behaviors | child involvement in food preparation | 2.9 score on a scale |
| Treatment as Usual Control Group | Parental Feeding Behaviors | feeding efficacy | 4.0 score on a scale |
| Treatment as Usual Control Group | Parental Feeding Behaviors | child involvement in food preparation | 2.8 score on a scale |
| Treatment as Usual Control Group | Parental Feeding Behaviors | repeated presentation of new foods | 3.2 score on a scale |
| Treatment as Usual Control Group | Parental Feeding Behaviors | measured child portion sizes | 2.5 score on a scale |
| Treatment as Usual Control Group | Parental Feeding Behaviors | feeding responsiveness | 3.4 score on a scale |
| Treatment as Usual Control Group | Parental Feeding Behaviors | knowledge of best feeding practices | 3.9 score on a scale |
| Treatment as Usual Control Group | Parental Feeding Behaviors | feeding misconceptions | 3.2 score on a scale |
p-value: <0.05Mixed Models Analysis