Obesity
Conditions
Keywords
Childhood obesity treatment, Motivational interviewing
Brief summary
Childhood obesity is a major public health problem in the U.S. Currently approximately one in three children is considered overweight or obese. Most overweight children grow to become overweight adults. It is unclear how effective pediatricians and other primary care physicians can be in assisting overweight children to normalize their body weight. Expert guidelines have been established, but are currently untested. This study will randomize overweight and obese children between the ages of 4 and 8 years old to either the recommended treatment guidelines or a control (non-intervention) group. The purpose of this study is to evaluate the ability (a) to recruit overweight children between the ages of 4 and 8 years old (b) to remeasure the children three months after enrollment and (c) to reduce childhood obesity via implementation of the recommended treatment guidelines.
Detailed description
3\. Research Plan: a. Specific Aims and Hypothesis: In 2007, an expert committee, composed of representatives from 16 major clinical organizations (including the PI of this proposal), published recommendations for primary care office-based treatment of childhood obesity. Seeking both clinical and cost-effectiveness, the recommendations call for staged treatment that starts with low intensity, and then, if unsuccessful, increases to a higher frequency of visits. The committee acknowledged that this staged approach has not been evaluated. Recent reviews conclude that treatment of childhood obesity can be efficacious. However, most studies were conducted in highly controlled tertiary care research settings and involved a large number of direct contact hours (e.g. many with ≥ 35 contact hours). Research evaluating the translation of these encouraging findings into more real-world clinical settings has been lacking. Specifically, there is little research assessing (1) the feasibility of recruitment from primary care clinics or (2) whether low intensity treatment (i.e. the initial phase of the staged approach recommended by the expert committee) has any benefit on weight loss. * Aim #1: To assess the feasibility of recruiting overweight and obese children, ages 4-8 years, from a large, urban pediatric primary care clinic, randomizing them to either low-intensity treatment or a control group, and then re-measuring them at approximately 3-months from the date of recruitment. o Our hypothesis is that we will be able to recruit approximately 70 parent/child dyads and re-measure 80% at 3-months. * Aim #2: To evaluate whether the proportion of children who decrease their BMI z-score over a 3-month period is higher in those randomly assigned to the intervention group compared with those in the control group. * Our hypothesis is that the intervention will result in a larger proportion of children decreasing BMI z-score over a 3-month period. Results from Aims 1 and 2 will be used to plan for an NIH proposal. If the low intensity treatment of this proposal shows a trend toward improvement over usual care, this will justify a full scale, R01 trial testing the complete recommendations of the expert committee. If few subjects in the intervention group have decreasing BMI z-scores, then a smaller NIH trial would be needed to test an amended low-intensity treatment stage with more parent/child contact (e.g. emails, home visits, phone calls).
Interventions
BEHAVIORALBehavioral counseling
Counseling of parents to improve their child's diet and physical activity
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* any patient at the participating clinic between the ages of 4-8 years who have a BMI ≥ the 85th percentile
Exclusion criteria
* emergent health concern * serious chronic health concern or recent gastrointestinal illness which may have resulted in weight loss * on medications known to affect weight
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index Z-score Change | Three months | Change in body mass index z-score change over the three month time period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sugar Sweetened Beverages | Three months | Change in reported intake of sugar sweetened beverages |
Countries
United States
Participant flow
Recruitment details
Study enrollment occurred from Sept 2011 - May 2012. Permission was first obtained from the clinicians and then the parent-child dyads who agreed gave written parental consent and, if the child was at least 8 years of age, child assent. Prior to randomization, a parent answered the intake survey and child ht and wt were re-measured by the RA.
Pre-assignment details
After enrollment, the children were randomly assigned to either the intervention or control group. The intervention and control group protocols began on the day of enrollment, immediately after group assignment
Participants by arm
| Arm | Count |
|---|---|
| Intervention - Behavioral Counseling The intervention group received management patterned after the Prevention plus, Stage 1 treatment recommended by the expert panel and approved by the committee. Counseling was primarily directed toward the parents. The RA used motivational interviewing (MI) techniques as an entry way to discuss healthy lifestyle habits around eating and physical activity (e.g., open-ended questions, reflective listening, discrepancy questions, eliciting change talk). Evidence-based recommendations for childhood obesity treatment were discussed with the parent; such as, eating breakfast daily, eating ≥ 5 servings of fruits and vegetables/day, avoidance of skipping meals, watching ≤ 2 hours of screen time/day, minimizing or eliminating sugar-sweetened beverages, encouraging family meals at home, and being physically active ≥ 1 hour/day.
There were monthly follow-up phone calls to try and encourage continued success in healthy lifestyle choices. | 35 |
| Control On the day of enrollment, after randomization to the control/usual care group, the RA provided age- and ability-appropriate informational hand-outs on school readiness and/or performance. | 37 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 4 |
Baseline characteristics
| Characteristic | Intervention - Behavioral Counseling | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 35 Participants | 37 Participants | 72 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| BMI- Z score | 1.90 z-score units STANDARD_DEVIATION 0.55 | 1.89 z-score units STANDARD_DEVIATION 0.82 | 1.90 z-score units STANDARD_DEVIATION 0.69 |
| Sex: Female, Male Female | 19 Participants | 18 Participants | 37 Participants |
| Sex: Female, Male Male | 16 Participants | 19 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 35 | 0 / 37 |
| serious Total, serious adverse events | 0 / 35 | 0 / 37 |
Outcome results
Primary
Body Mass Index Z-score Change
Change in body mass index z-score change over the three month time period
Time frame: Three months
Population: All enrolled were analyzed with one exception (due to injury and prolonged cast treatment). An intent-to-treat analysis required that, for those who did not have the follow-up measurement, data were filled in using the experience of those in the control group who had follow-up measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention - Behavioral Counseling | Body Mass Index Z-score Change | -0.02 BMI z-score change | Standard Error 0.05 |
| Control | Body Mass Index Z-score Change | -0.08 BMI z-score change | Standard Error 0.05 |
Comparison: Baseline data by group assignment status (intervention or control) using means of the calculated BMI z-scores (U.S. CDC-2000 growth charts) implemented by applying the published LMS (shape, median, and scale) age- and sex/gender-specific parameters. Because of random assignment of a reasonably large number of children, an unadjusted analysis of change in outcomes between intervention and control groups is presented as well as the covariate-adjusted analysis of differences in changes.95% CI: [-0.1, 0.21]
Secondary
Sugar Sweetened Beverages
Change in reported intake of sugar sweetened beverages
Time frame: Three months
Population: Intention to treat analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention - Behavioral Counseling | Sugar Sweetened Beverages | -0.14 cans per day | Standard Error 0.2 |
| Control | Sugar Sweetened Beverages | 0.03 cans per day | Standard Error 0.2 |
Comparison: unadjusted net difference between groups95% CI: [-0.74, 0.4]