Trial Outcomes & Findings for Cognitive Aspects of Response to Treatment for Weight-related Health to Improve Eating and Exercise Earlier in Life (NCT NCT03329300)

NCT ID: NCT03329300

Last Updated: 2023-11-07

Results Overview

Dual-energy X-ray Absorptiometry (DXA)

Recruitment status

COMPLETED

Study phase

Target enrollment

34 participants

Primary outcome timeframe

Baseline to 6 months

Results posted on

2023-11-07

Participant Flow

Participant milestones

Participant milestones
Measure	Children Family-based Behavioral Treatment (FBT) Family-based Behavioral Treatment (FBT): Family-based behavioral treatment (FBT) involves working with children and caregivers to modify diet and physical activity using behavioral strategies such as problem solving, goal setting, and self-monitoring. Children and caregivers will meet in group format on a weekly basis for 6 months. There will be 24 group session total, covering a variety of topics including nutrition, physical activity, and other aspects of health and wellness.	Parents/Caregivers Family-based Behavioral Treatment (FBT) Family-based Behavioral Treatment (FBT): Family-based behavioral treatment (FBT) involves working with children and caregivers to modify diet and physical activity using behavioral strategies such as problem solving, goal setting, and self-monitoring. Children and caregivers will meet in group format on a weekly basis for 6 months. There will be 24 group session total, covering a variety of topics including nutrition, physical activity, and other aspects of health and wellness.
Overall Study STARTED	17	17
Overall Study COMPLETED	17	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

DXA scans were not performed on parents/caregivers

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: DXA scans were not performed on parents.caregivers.

Dual-energy X-ray Absorptiometry (DXA)

Outcome measures

Outcome measures
Measure	Children n=12 Participants There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.	Parents/Caregivers There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.
Change From Baseline Child Body Fat Mass at 6 Months	-.96 %bf tblh (total body less head) Standard Deviation 3.71	—

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: Assessed on the dyad level

The number of contact hours participant was exposed to treatment

Outcome measures

Outcome measures
Measure	Children n=17 Participants There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.	Parents/Caregivers There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.
Adherence to Treatment (Number of Contact Hours)	11.48 hours Standard Deviation 10.49	—

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: Data were not collected; USDA Supertracker software was discontinued and thus not able to be used to collect data as planned.

The number of completed days of diet/activity self-monitoring using the USDA SuperTracker software, defined by ≥2 meals and exercise minutes recorded daily.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6 months

Height will be measured to the nearest 0.1 cm with a Seca 213 portable stadiometer.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6 months

Weight will be measured to the nearest 0.1 kg with a Tanita SC-240 bio-electrical impedance (BIA) analyzer and standard scale.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6 months

Population: Parent/caregiver BMI not reported as zscore

Body mass index z-scores are measures of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Change in child BMI z-score was calculated by subtracting child BMI z-score at 6 months from child BMI z-score at baseline. Negative scores indicate that BMI z-score decreased across the 6 month treatment period (i.e., better outcome), whereas positive scores indicate that BMI z-score increased from 0 to 6 months (i.e., worse outcome).

Outcome measures

Outcome measures
Measure	Children n=13 Participants There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.	Parents/Caregivers There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.
Change in Child Body Mass Index	-.05 z-score Standard Deviation .05	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6 months

Height will be measured to the nearest 0.1 cm with a Seca 213 portable stadiometer.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6 months

Weight will be measured to the nearest 0.1 kg with a Tanita SC-240 bio-electrical impedance (BIA) analyzer and standard scale.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6 months

Population: Child BMI change not calculated using raw scores.

Parent/guardian height and weight will be used together to determine BMI (kg/m\^2). Raw BMI score at 6 months was subtracted from raw BMI score at baseline to calculate the change in BMI score from 0 to 6 months (i.e., treatment duration). Negative scores indicate a decrease in BMI (i.e., better outcome) whereas positive scores indicated an increase in BMI (i.e., worse outcome) from baseline to 6 months.

Outcome measures

Outcome measures
Measure	Children There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.	Parents/Caregivers n=13 Participants There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.
Change in Parent/Guardian Body Mass Index	—	-.48 kg/m^2 Standard Deviation 1.02

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6 months

Performance-based EF was tested using the NIH Toolbox Cognitive Battery. NIH Toolbox T-scores were used (Mean=50, Standard deviation=10). Change in EF was calculated by subtracting the T-score at 6 months from the T-score at baseline. Positive change scores indicate an improvement in EF from baseline to 6 months, whereas negative change scores indicate a decline in EF from baseline to 6 months.

Outcome measures

Outcome measures
Measure	Children n=10 Participants There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.	Parents/Caregivers n=10 Participants There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.
Change in Executive Functioning - Inhibitory Control	3.3 t-score Standard Deviation 5.43	-2.00 t-score Standard Deviation 5.39

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6 months

Outcome measures

Outcome measures
Measure	Children n=10 Participants There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.	Parents/Caregivers n=10 Participants There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.
Change in Executive Functioning - Working Memory	.40 t-score Standard Deviation 6.36	4.30 t-score Standard Deviation 6.75

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6 months

Outcome measures

Outcome measures
Measure	Children n=10 Participants There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.	Parents/Caregivers n=10 Participants There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.
Change in Executive Functioning - Cognitive Flexibility	5.40 t-score Standard Deviation 7.26	6.40 t-score Standard Deviation 12.81

Adverse Events

Children

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Parents/Caregivers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marissa Gowey, PhD

University of Alabama at Birmingham Department of Pediatrics

Phone: 2056386618

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Children n=17 Participants There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.	Parents/Caregivers n=17 Participants There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only.	Total n=34 Participants Total of all reporting groups
Age, Continuous	12 years STANDARD_DEVIATION 1.6 • n=17 Participants	42.3 years STANDARD_DEVIATION 8.9 • n=17 Participants	26.21 years STANDARD_DEVIATION 17.5 • n=34 Participants
Sex: Female, Male Female	13 Participants n=17 Participants	17 Participants n=17 Participants	30 Participants n=34 Participants
Sex: Female, Male Male	4 Participants n=17 Participants	0 Participants n=17 Participants	4 Participants n=34 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=17 Participants	3 Participants n=17 Participants	6 Participants n=34 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=17 Participants	13 Participants n=17 Participants	26 Participants n=34 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=17 Participants	1 Participants n=17 Participants	2 Participants n=34 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=34 Participants
Race (NIH/OMB) Asian	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=34 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=34 Participants
Race (NIH/OMB) Black or African American	11 Participants n=17 Participants	11 Participants n=17 Participants	22 Participants n=34 Participants
Race (NIH/OMB) White	5 Participants n=17 Participants	6 Participants n=17 Participants	11 Participants n=34 Participants
Race (NIH/OMB) More than one race	1 Participants n=17 Participants	0 Participants n=17 Participants	1 Participants n=34 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=17 Participants	0 Participants n=17 Participants	0 Participants n=34 Participants
Region of Enrollment United States	17 participants n=17 Participants	17 participants n=17 Participants	34 participants n=34 Participants
Child Body Fat Mass (DXA)	48.8 %bf tblh (total body less head) STANDARD_DEVIATION 5.34 • n=17 Participants • DXA scans were not performed on parents/caregivers	—	48.8 %bf tblh (total body less head) STANDARD_DEVIATION 5.34 • n=17 Participants • DXA scans were not performed on parents/caregivers
Child Body Mass Index	2.41 Z-score STANDARD_DEVIATION 0.36 • n=17 Participants • Only child BMI is reported as a zscore	—	2.41 Z-score STANDARD_DEVIATION 0.36 • n=17 Participants • Only child BMI is reported as a zscore
Parent Body Mass Index	—	37.2 BMI Percentile STANDARD_DEVIATION 12.6 • n=17 Participants • Only parent/caregiver BMI is reported as percentile	37.2 BMI Percentile STANDARD_DEVIATION 12.6 • n=17 Participants • Only parent/caregiver BMI is reported as percentile
Height	149.24 cm STANDARD_DEVIATION 7.27 • n=17 Participants	163.35 cm STANDARD_DEVIATION 4.91 • n=17 Participants	156.30 cm STANDARD_DEVIATION 9.41 • n=34 Participants
Weight	74.67 kg STANDARD_DEVIATION 20.11 • n=17 Participants	98.20 kg STANDARD_DEVIATION 32.44 • n=17 Participants	86.44 kg STANDARD_DEVIATION 29.14 • n=34 Participants
Executive Functioning	52.12 t-score STANDARD_DEVIATION 11.11 • n=17 Participants	52.71 t-score STANDARD_DEVIATION 10.7 • n=17 Participants	52.41 t-score STANDARD_DEVIATION 10.74 • n=34 Participants