Trial Outcomes & Findings for Healthy Kids I-PAL (NCT NCT03297541)

Last Updated: 2024-11-07

Results Overview

Children completed an acceptability survey at the end of the intervention that included Likert scales on intervention satisfaction. The items were average to calculate an average acceptability score. The scale range for the average total score is 1 to 5. A higher score indicates higher acceptability.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

13 Weeks

Results posted on

2024-11-07

Participant Flow

Participant milestones

Participant milestones
Measure	M-health Approach All dyads will receive the m-health approach. m-health approach: Parent/child dyads attend remote counseling sessions delivered over Internet-connected device (e.g. smartphone, iPad/tablet, laptop, or desktop computer). A counselor will deliver the lesson, review progress based on the objectively measured data, and provide individualized advice and problem-solving strategies for parent and child. Families will receive weekly contact via smartphone. Each lesson will include an interactive component for parent and child related to healthy eating and active play, as well as an interactive parenting training component. Lessons are based on the family treatment methods that effectively promote child and parent weight loss that is sustained for 10 years (Epstein et al., 1990; Epstein et al., 1981).
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Healthy Kids I-PAL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Child Participants in the Dyads n=10 Participants All dyads will receive the m-health approach. m-health approach: Parent/child dyads attend remote counseling sessions delivered over Internet-connected device (e.g. smartphone, iPad/tablet, laptop, or desktop computer). A counselor will deliver the lesson, review progress based on the objectively measured data, and provide individualized advice and problem-solving strategies for parent and child. Families will receive weekly contact via smartphone. Each lesson will include an interactive component for parent and child related to healthy eating and active play, as well as an interactive parenting training component. Lessons are based on the family treatment methods that effectively promote child and parent weight loss that is sustained for 10 years (Epstein et al., 1990; Epstein et al., 1981).
Age, Categorical <=18 years	10 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	7.8 years STANDARD_DEVIATION 2.3 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 13 Weeks

Outcome measures

Outcome measures
Measure	M-health Approach n=10 Participants All dyads will receive the m-health approach. m-health approach: Parent/child dyads attend remote counseling sessions delivered over Internet-connected device (e.g. smartphone, iPad/tablet, laptop, or desktop computer). A counselor will deliver the lesson, review progress based on the objectively measured data, and provide individualized advice and problem-solving strategies for parent and child. Families will receive weekly contact via smartphone. Each lesson will include an interactive component for parent and child related to healthy eating and active play, as well as an interactive parenting training component. Lessons are based on the family treatment methods that effectively promote child and parent weight loss that is sustained for 10 years (Epstein et al., 1990; Epstein et al., 1981).
Child Acceptability of the mHealth Approach	3.8 score on a scale Standard Deviation .5

SECONDARY outcome

Timeframe: Week 0 to Week 14-16

Objectively measured height and weight were compared against the normative values for age (months) and sex according to the CDC growth charts. A z-score is assigned, with 0 representing the population mean. A positive z-score indicates a BMI above the population mean (higher relative weight), whereas a negative z-score is below the population mean (lower relative weight). For the change score, the post BMI z-score measured at week 14-16 was subtracted from the baseline BMI z-score. For the change score, a positive value indicates an increase in relative weight, whereas a negative value indicates a reduction in relative weight.

Outcome measures

Outcome measures
Measure	M-health Approach n=10 Participants All dyads will receive the m-health approach. m-health approach: Parent/child dyads attend remote counseling sessions delivered over Internet-connected device (e.g. smartphone, iPad/tablet, laptop, or desktop computer). A counselor will deliver the lesson, review progress based on the objectively measured data, and provide individualized advice and problem-solving strategies for parent and child. Families will receive weekly contact via smartphone. Each lesson will include an interactive component for parent and child related to healthy eating and active play, as well as an interactive parenting training component. Lessons are based on the family treatment methods that effectively promote child and parent weight loss that is sustained for 10 years (Epstein et al., 1990; Epstein et al., 1981).
BMI Z-score Change	-0.14 Z-Score Standard Deviation 0.17

Adverse Events

Child Participants in the Dyads

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Parent Participants in the Dyads

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. Amanda Staiano

LSU's Pennington Biomedical Research Center

Phone: 2257632500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place