Trial Outcomes & Findings for A Trial of Two Family-based Childhood Obesity Treatment Programs (NCT NCT03245775)

Last Updated: 2024-06-28

Results Overview

child BMI is converted to a BMI Z score which uses a standardized distribution. A BMI z score of 0 indicates an average BMI for the childs height, weight, age, and gender. Positive z-scores indicate the number of standard deviations above the norm, while negative numbers indicate the number of standard deviations below the norm. Higher z scores indicate a greater BMI status for the child. The primary outcome is a change score, or the difference between the 6 month BMI z-score and the Baseline BMI z-score. A negative score will indicate BMI z score status reductions and is a positive finding.

Recruitment status

COMPLETED

Study phase

Target enrollment

267 participants

Primary outcome timeframe

Baseline and 6-months

Results posted on

2024-06-28

Participant Flow

Participant milestones

Participant milestones
Measure	iChoose-Parent 12 bi-weekly sessions \& 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only iChoose: 12 bi-weekly sessions \& 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only	iChoose-Child 12 bi-weekly sessions \& 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only iChoose: 12 bi-weekly sessions \& 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only	Family Connections-Parent 2 in-person sessions spaced one week apart \& 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only Family Connections: 2 in-person sessions spaced one week apart \& 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only	Family Connections-Child 2 in-person sessions spaced one week apart \& 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only. Children are enrolled and assessed at baseline and 6 months. Family Connections: 2 in-person sessions spaced one week apart \& 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only. Children are enrolled and assessed at baseline, 3 months, and 6 months.
Overall Study STARTED	66	70	62	69
Overall Study COMPLETED	41	44	46	53
Overall Study NOT COMPLETED	25	26	16	16

Reasons for withdrawal

Reasons for withdrawal
Measure	iChoose-Parent 12 bi-weekly sessions \& 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only iChoose: 12 bi-weekly sessions \& 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only	iChoose-Child 12 bi-weekly sessions \& 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only iChoose: 12 bi-weekly sessions \& 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only	Family Connections-Parent 2 in-person sessions spaced one week apart \& 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only Family Connections: 2 in-person sessions spaced one week apart \& 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only	Family Connections-Child 2 in-person sessions spaced one week apart \& 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only. Children are enrolled and assessed at baseline and 6 months. Family Connections: 2 in-person sessions spaced one week apart \& 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only. Children are enrolled and assessed at baseline, 3 months, and 6 months.
Overall Study Lost to Follow-up	25	26	16	16

Baseline Characteristics

A Trial of Two Family-based Childhood Obesity Treatment Programs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	iChoose-Parent n=66 Participants 12 bi-weekly sessions \& 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only iChoose: 12 bi-weekly sessions \& 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only	iChoose-Child n=70 Participants 12 bi-weekly sessions \& 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only iChoose: 12 bi-weekly sessions \& 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only	Family Connections-Parent n=62 Participants 2 in-person sessions spaced one week apart \& 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only Family Connections: 2 in-person sessions spaced one week apart \& 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only	Family Connections-Child n=69 Participants 2 in-person sessions spaced one week apart \& 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only Family Connections: 2 in-person sessions spaced one week apart \& 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only	Total n=267 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	70 Participants n=7 Participants	0 Participants n=5 Participants	69 Participants n=4 Participants	139 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	66 Participants n=5 Participants	0 Participants n=7 Participants	61 Participants n=5 Participants	0 Participants n=4 Participants	127 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Age, Continuous	38.8 years STANDARD_DEVIATION 7.2 • n=5 Participants	10.1 years STANDARD_DEVIATION 1.7 • n=7 Participants	39 years STANDARD_DEVIATION 9.6 • n=5 Participants	10.0 years STANDARD_DEVIATION 1.7 • n=4 Participants	10.1 years STANDARD_DEVIATION 1.7 • n=21 Participants
Sex: Female, Male Female	64 Participants n=5 Participants	46 Participants n=7 Participants	60 Participants n=5 Participants	34 Participants n=4 Participants	204 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	24 Participants n=7 Participants	2 Participants n=5 Participants	35 Participants n=4 Participants	63 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	13 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	25 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	63 Participants n=5 Participants	57 Participants n=7 Participants	59 Participants n=5 Participants	63 Participants n=4 Participants	242 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	33 Participants n=5 Participants	31 Participants n=7 Participants	29 Participants n=5 Participants	31 Participants n=4 Participants	124 Participants n=21 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	35 Participants n=7 Participants	30 Participants n=5 Participants	31 Participants n=4 Participants	128 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants	15 Participants n=21 Participants
Region of Enrollment United States	66 participants n=5 Participants	70 participants n=7 Participants	62 participants n=5 Participants	69 participants n=4 Participants	267 participants n=21 Participants
BMI status Normal	8 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	9 Participants n=21 Participants
BMI status Overweight	9 Participants n=5 Participants	20 Participants n=7 Participants	12 Participants n=5 Participants	21 Participants n=4 Participants	62 Participants n=21 Participants
BMI status Obese	49 Participants n=5 Participants	50 Participants n=7 Participants	49 Participants n=5 Participants	48 Participants n=4 Participants	196 Participants n=21 Participants
Health Insurance Type Medicaid	19 Participants n=5 Participants	41 Participants n=7 Participants	20 Participants n=5 Participants	45 Participants n=4 Participants	125 Participants n=21 Participants
Health Insurance Type Private	35 Participants n=5 Participants	25 Participants n=7 Participants	28 Participants n=5 Participants	21 Participants n=4 Participants	109 Participants n=21 Participants
Health Insurance Type None	6 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	1 Participants n=4 Participants	15 Participants n=21 Participants
Health Insurance Type Medicare	2 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants
Health Insurance Type Other	4 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	11 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and 6-months

Outcome measures

Outcome measures
Measure	iChoose-Child n=70 Participants 12 bi-weekly sessions \& 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only iChoose: 12 bi-weekly sessions \& 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only	Family Connections-Child n=69 Participants 2 in-person sessions spaced one week apart \& 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only Family Connections: 2 in-person sessions spaced one week apart \& 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only
Change From Baseline in Child Body Mass Index (BMI) Z-score at 6 Months	0.03 z-scores Interval -0.13 to 0.19	0.00 z-scores Interval -0.16 to 0.16

SECONDARY outcome

Timeframe: Baseline and 6-months

BMI is the persons weight divided by the square of their height. BMI categories help to classify individuals as underweight (less than 18.5), normal (18.5-24.9), overweight (25-29.9), and obese (30 or higher). Parent BMI change scores are the difference between the 6 month calculated BMI and the Baseline BMI. Negative scores indicate improvement in BMI status over this 6 month period.

Outcome measures

Outcome measures
Measure	iChoose-Child n=66 Participants 12 bi-weekly sessions \& 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only iChoose: 12 bi-weekly sessions \& 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only	Family Connections-Child n=62 Participants 2 in-person sessions spaced one week apart \& 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only Family Connections: 2 in-person sessions spaced one week apart \& 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only
Change From Baseline of Parent Body Mass Index (BMI) at 6 Months	-1.04 kg/m^2 Interval -4.15 to 2.08	0.04 kg/m^2 Interval -2.95 to 3.02

SECONDARY outcome

Timeframe: Baseline and 6-months

The Pediatric Quality of Life Inventory is a 23-item instruments that assesses four domains of health (physical, emotional, social, and school functioning). Scoring is reported as a percent (0-100), higher scores indicate better health related quality of life. The change score is calculated as the difference between the 6 month and baseline scores. A positive difference is considered an improvement in quality of life.

Outcome measures

Outcome measures
Measure	iChoose-Child n=70 Participants 12 bi-weekly sessions \& 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only iChoose: 12 bi-weekly sessions \& 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only	Family Connections-Child n=69 Participants 2 in-person sessions spaced one week apart \& 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only Family Connections: 2 in-person sessions spaced one week apart \& 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only
Change From Baseline in the Pediatric Quality of Life Inventory for Children Score at 6 Months	-0.7 score on a scale Interval -7.3 to 5.9	5.0 score on a scale Interval -0.5 to 10.4

SECONDARY outcome

Timeframe: Baseline and 6-months

The Healthy Days Core Module is a measure of quality of life through self reports of the total number of physical and mental health "sick days" (e.g., unable to do daily activities) in the past month. Higher scores indicate more unhealthy days, or lower quality of life. Change scores are calculated as the difference between 6 month and baseline scores. A negative change score indicates a decrease in unhealthy days and thereby and increase in quality of life.

Outcome measures

Outcome measures
Measure	iChoose-Child n=66 Participants 12 bi-weekly sessions \& 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only iChoose: 12 bi-weekly sessions \& 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only	Family Connections-Child n=62 Participants 2 in-person sessions spaced one week apart \& 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only Family Connections: 2 in-person sessions spaced one week apart \& 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only
Change From Baseline in the Healthy Days Core Module for Parents at 6 Months	3.1 number of unhealthy days in past month Interval -1.4 to 7.5	-3.8 number of unhealthy days in past month Interval -8.2 to 0.5

Adverse Events

iChoose-Parent

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

iChoose-Child

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Family Connections-Child

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Family Connections-Parent

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

Dr. Jamie Zoellner, Professor of Public Health Sciences

University of Virginia

Phone: 4349624488

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place