Trial Outcomes & Findings for Family-based Lifestyle Intervention Program and Carotenoid Supplementation for Children With Obesity (NCT NCT02060279)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

6 months

Results posted on

2024-07-18

Participant Flow

Participant milestones

Participant milestones
Measure	Lifestyle Intervention and Carotenoid Supplement Lifestyle intervention and carotenoid supplements: 2 week intervention partial hospitalization program followed by 8 bi-monthly sessions of a lifestyle intervention group run by a psychologist or health coach (research assistant). The entire intervention will last approximately 6 months. Children will participate in all aspects of the intervention including: dietary groups, life coaching, art and music therapy, school based learning, group therapy, physical activity, cooking, preparing meals, family therapy sessions, and yoga. The participants randomized to this study arm will also take Jarrow Formulas CaroteneAll® (5000 IU) supplement while at the intervention site for 2 weeks and then will continue to take the supplements for up to 6 months until their participation in the study is complete. Two capsules of supplement will be consumed daily with a meal with 6 oz. of water.	Lifestyle Intervention and Placebo Lifestyle intervention and placebo: 2 week intervention partial hospitalization program followed by 8 bi-monthly sessions of a lifestyle intervention group run by a psychologist or health coach (research assistant). The entire intervention will last approximately 6 months. Children will participate in all aspects of the intervention including: dietary groups, life coaching, art and music therapy, school based learning, group therapy, physical activity, cooking, preparing meals, family therapy sessions, and yoga. The participants randomized to this study arm will also take a placebo while at the intervention site for 2 weeks and then will continue to take the placebo for up to 6 months until their participation in the study is complete. Two capsules of placebo will be consumed daily with a meal with 6 oz. of water.
Overall Study STARTED	10	10
Overall Study COMPLETED	8	9
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Family-based Lifestyle Intervention Program and Carotenoid Supplementation for Children With Obesity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lifestyle Intervention and Carotenoid Supplement n=10 Participants Lifestyle intervention and carotenoid supplements: 2 week intervention partial hospitalization program followed by 8 bi-monthly sessions of a lifestyle intervention group run by a psychologist or health coach (research assistant). The entire intervention will last approximately 6 months. Children will participate in all aspects of the intervention including: dietary groups, life coaching, art and music therapy, school based learning, group therapy, physical activity, cooking, preparing meals, family therapy sessions, and yoga. The participants randomized to this study arm will also take Jarrow Formulas CaroteneAll® (5000 IU) supplement while at the intervention site for 2 weeks and then will continue to take the supplements for up to 6 months until their participation in the study is complete. Two capsules of supplement will be consumed daily with a meal with 6 oz. of water.	Lifestyle Intervention and Placebo n=10 Participants Lifestyle intervention and placebo: 2 week intervention partial hospitalization program followed by 8 bi-monthly sessions of a lifestyle intervention group run by a psychologist or health coach (research assistant). The entire intervention will last approximately 6 months. Children will participate in all aspects of the intervention including: dietary groups, life coaching, art and music therapy, school based learning, group therapy, physical activity, cooking, preparing meals, family therapy sessions, and yoga. The participants randomized to this study arm will also take a placebo while at the intervention site for 2 weeks and then will continue to take the placebo for up to 6 months until their participation in the study is complete. Two capsules of placebo will be consumed daily with a meal with 6 oz. of water.	Total n=20 Participants Total of all reporting groups
Age, Continuous	125 months STANDARD_DEVIATION 4.9 • n=5 Participants	126 months STANDARD_DEVIATION 4.7 • n=7 Participants	126 months STANDARD_DEVIATION 4.8 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Lifestyle Intervention and Carotenoid Supplement n=8 Participants Lifestyle intervention and carotenoid supplements: 2 week intervention partial hospitalization program followed by 8 bi-monthly sessions of a lifestyle intervention group run by a psychologist or health coach (research assistant). The entire intervention will last approximately 6 months. Children will participate in all aspects of the intervention including: dietary groups, life coaching, art and music therapy, school based learning, group therapy, physical activity, cooking, preparing meals, family therapy sessions, and yoga. The participants randomized to this study arm will also take Jarrow Formulas CaroteneAll® (5000 IU) supplement while at the intervention site for 2 weeks and then will continue to take the supplements for up to 6 months until their participation in the study is complete. Two capsules of supplement will be consumed daily with a meal with 6 oz. of water.	Lifestyle Intervention and Placebo n=9 Participants Lifestyle intervention and placebo: 2 week intervention partial hospitalization program followed by 8 bi-monthly sessions of a lifestyle intervention group run by a psychologist or health coach (research assistant). The entire intervention will last approximately 6 months. Children will participate in all aspects of the intervention including: dietary groups, life coaching, art and music therapy, school based learning, group therapy, physical activity, cooking, preparing meals, family therapy sessions, and yoga. The participants randomized to this study arm will also take a placebo while at the intervention site for 2 weeks and then will continue to take the placebo for up to 6 months until their participation in the study is complete. Two capsules of placebo will be consumed daily with a meal with 6 oz. of water.
Change in β-carotene Baseline	.127 ug/mL Standard Error .024	.116 ug/mL Standard Error .019
Change in β-carotene 6 Month	.224 ug/mL Standard Error .024	.107 ug/mL Standard Error .023

PRIMARY outcome

Timeframe: 6 months

Population: Although 17 participants completed all requirements of the study, there was 1 additional participant that completed partial measures, resulting in 18 participants that completed the BMI measure.

Body Mass Index (kg/m\*2) was calculated using body mass and height. Body Mass Index z-scores were generated according to the U.S. Centers for Disease Control and Prevention reference criteria. Z-scores range from -3 to 3 and a z-score of 0 represents the population mean. Higher z-score values indicate worse outcomes. The Centers for Disease Control has defined obesity as a z-score \> 1.64 and overweight as a z-score \> 1.04.

Outcome measures

Outcome measures
Measure	Lifestyle Intervention and Carotenoid Supplement n=8 Participants Lifestyle intervention and carotenoid supplements: 2 week intervention partial hospitalization program followed by 8 bi-monthly sessions of a lifestyle intervention group run by a psychologist or health coach (research assistant). The entire intervention will last approximately 6 months. Children will participate in all aspects of the intervention including: dietary groups, life coaching, art and music therapy, school based learning, group therapy, physical activity, cooking, preparing meals, family therapy sessions, and yoga. The participants randomized to this study arm will also take Jarrow Formulas CaroteneAll® (5000 IU) supplement while at the intervention site for 2 weeks and then will continue to take the supplements for up to 6 months until their participation in the study is complete. Two capsules of supplement will be consumed daily with a meal with 6 oz. of water.	Lifestyle Intervention and Placebo n=10 Participants Lifestyle intervention and placebo: 2 week intervention partial hospitalization program followed by 8 bi-monthly sessions of a lifestyle intervention group run by a psychologist or health coach (research assistant). The entire intervention will last approximately 6 months. Children will participate in all aspects of the intervention including: dietary groups, life coaching, art and music therapy, school based learning, group therapy, physical activity, cooking, preparing meals, family therapy sessions, and yoga. The participants randomized to this study arm will also take a placebo while at the intervention site for 2 weeks and then will continue to take the placebo for up to 6 months until their participation in the study is complete. Two capsules of placebo will be consumed daily with a meal with 6 oz. of water.
BMI Z-score Baseline	2.50 Z-score Standard Error .07	1.97 Z-score Standard Error .13
BMI Z-score 6 Month	2.25 Z-score Standard Error .13	1.88 Z-score Standard Error .19

PRIMARY outcome

Timeframe: 6 months

Population: Although 17 participants completed all requirements of the study, there was 1 additional participant that completed partial measures, resulting in 18 participants that completed the waist to height ratio measure.

Outcome measures

Outcome measures
Measure	Lifestyle Intervention and Carotenoid Supplement n=8 Participants Lifestyle intervention and carotenoid supplements: 2 week intervention partial hospitalization program followed by 8 bi-monthly sessions of a lifestyle intervention group run by a psychologist or health coach (research assistant). The entire intervention will last approximately 6 months. Children will participate in all aspects of the intervention including: dietary groups, life coaching, art and music therapy, school based learning, group therapy, physical activity, cooking, preparing meals, family therapy sessions, and yoga. The participants randomized to this study arm will also take Jarrow Formulas CaroteneAll® (5000 IU) supplement while at the intervention site for 2 weeks and then will continue to take the supplements for up to 6 months until their participation in the study is complete. Two capsules of supplement will be consumed daily with a meal with 6 oz. of water.	Lifestyle Intervention and Placebo n=10 Participants Lifestyle intervention and placebo: 2 week intervention partial hospitalization program followed by 8 bi-monthly sessions of a lifestyle intervention group run by a psychologist or health coach (research assistant). The entire intervention will last approximately 6 months. Children will participate in all aspects of the intervention including: dietary groups, life coaching, art and music therapy, school based learning, group therapy, physical activity, cooking, preparing meals, family therapy sessions, and yoga. The participants randomized to this study arm will also take a placebo while at the intervention site for 2 weeks and then will continue to take the placebo for up to 6 months until their participation in the study is complete. Two capsules of placebo will be consumed daily with a meal with 6 oz. of water.
Waist to Height Ratio Baseline	.69 ratio Standard Deviation .06	.62 ratio Standard Deviation .06
Waist to Height Ratio 6 Months	.65 ratio Standard Deviation .09	.62 ratio Standard Deviation .08

Adverse Events

Lifestyle Intervention and Carotenoid Supplement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lifestyle Intervention and Placebo

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 Lochrie

Nemours Children's Specialty Care

Phone: 904-697-3698

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place