Trial Outcomes & Findings for For the Health of Our Children--Clinic Based Treatment of Childhood Obesity (NCT NCT01625910)
NCT ID: NCT01625910
Last Updated: 2017-03-09
Results Overview
Change in body mass index z-score change over the three month time period
COMPLETED
NA
72 participants
Three months
2017-03-09
Participant Flow
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.
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
Participant milestones
| Measure |
Intervention - Behavioral Counseling
The intervention group received management patterned after the
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
37
|
|
Overall Study
COMPLETED
|
32
|
33
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Intervention - Behavioral Counseling
The intervention group received management patterned after the
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
Baseline Characteristics
For the Health of Our Children--Clinic Based Treatment of Childhood Obesity
Baseline characteristics by cohort
| Measure |
Intervention - Behavioral Counseling
n=35 Participants
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.
|
Control
n=37 Participants
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.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
35 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
BMI- Z score
|
1.90 z-score units
STANDARD_DEVIATION 0.55 • n=5 Participants
|
1.89 z-score units
STANDARD_DEVIATION 0.82 • n=7 Participants
|
1.90 z-score units
STANDARD_DEVIATION 0.69 • n=5 Participants
|
PRIMARY outcome
Timeframe: Three monthsPopulation: 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.
Change in body mass index z-score change over the three month time period
Outcome measures
| Measure |
Intervention - Behavioral Counseling
n=35 Participants
The intervention group received management patterned after the
|
Control
n=36 Participants
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.
|
|---|---|---|
|
Body Mass Index Z-score Change
|
-0.02 BMI z-score change
Standard Error 0.05
|
-0.08 BMI z-score change
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Three monthsPopulation: Intention to treat analysis
Change in reported intake of sugar sweetened beverages
Outcome measures
| Measure |
Intervention - Behavioral Counseling
n=35 Participants
The intervention group received management patterned after the
|
Control
n=36 Participants
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.
|
|---|---|---|
|
Sugar Sweetened Beverages
|
-0.14 cans per day
Standard Error 0.20
|
0.03 cans per day
Standard Error 0.20
|
Adverse Events
Intervention - Behavioral Counseling
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Steven D. Stovitz, MD, MS
University of Minnesota, Department of Family Medicine and Community Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place