A Trial To Study The Effects Of Group Versus Individual Dietary Counseling In Pediatric Obesity
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 9 - 17 |
| Updated: | 10/14/2018 |
| Start Date: | April 2013 |
| End Date: | June 1, 2018 |
A Randomized Controlled Trial To Study The Effects Of Group Versus Individual Dietary Counseling In Pediatric Obesity
Aim 1 - The primary aim of the study is to assess whether group counseling is a non-inferior
intervention compared to the usual care of individual counseling in the management of
childhood obesity. In order to achieve this aim, the investigators will compare the mean
change in BMI after 6 months of intervention in the two study arms.
Aim 2 - The secondary aim of the study is to determine if the change in BMI is associated
with changes in the dietary composition, physical activity and metabolic profile.
intervention compared to the usual care of individual counseling in the management of
childhood obesity. In order to achieve this aim, the investigators will compare the mean
change in BMI after 6 months of intervention in the two study arms.
Aim 2 - The secondary aim of the study is to determine if the change in BMI is associated
with changes in the dietary composition, physical activity and metabolic profile.
This is a non-inferiority study to determine the sample size needed for a larger study to
explore an intervention strategy focused on nutrition counseling to maximize weight loss and
minimize cardiovascular risk factors in obese children and adolescents. This is a prospective
parallel arm, randomized trial, to study the impact of nutritional counseling in an
individual vs. group setting. There will be a total of four groups. Obese pre-adolescents
(ages 9-12) and adolescents (ages 13-17) will be randomized into two interventions:
individual nutrition counseling or group nutrition counseling. Subjects will receive the same
information in both interventions. All content will be developed prior to starting the
intervention. Each group session will have a maximum of 7 children with 1 parent/caregiver
per child and a minimum of 5 children with a caregiver. Group sessions will be one time a
month for 60 minutes (30 minutes for dietetic session and 30 minutes for
discussion/questions) and individual sessions will be one time a month for 30 minutes. There
will be 6 sessions for each group.
All groups will receive standard of care for physical fitness counseling which includes
recommending 1 hour of physical activity a day and limiting screen time to less than 2 hours
a day. All groups will be evaluated for depression and appropriately referred if found to be
depressed. Behavioral strategies, like mindful eating, will be included in the nutrition
education.
explore an intervention strategy focused on nutrition counseling to maximize weight loss and
minimize cardiovascular risk factors in obese children and adolescents. This is a prospective
parallel arm, randomized trial, to study the impact of nutritional counseling in an
individual vs. group setting. There will be a total of four groups. Obese pre-adolescents
(ages 9-12) and adolescents (ages 13-17) will be randomized into two interventions:
individual nutrition counseling or group nutrition counseling. Subjects will receive the same
information in both interventions. All content will be developed prior to starting the
intervention. Each group session will have a maximum of 7 children with 1 parent/caregiver
per child and a minimum of 5 children with a caregiver. Group sessions will be one time a
month for 60 minutes (30 minutes for dietetic session and 30 minutes for
discussion/questions) and individual sessions will be one time a month for 30 minutes. There
will be 6 sessions for each group.
All groups will receive standard of care for physical fitness counseling which includes
recommending 1 hour of physical activity a day and limiting screen time to less than 2 hours
a day. All groups will be evaluated for depression and appropriately referred if found to be
depressed. Behavioral strategies, like mindful eating, will be included in the nutrition
education.
Inclusion Criteria:
- Subjects 9-17 years of age with a BMI percentile for age of ≥95
- Subjects must be able to attend monthly sessions with a parent and/or guardian.
Exclusion Criteria:
- Subjects with diabetes at baseline, mental or psychological disease that would
interfere with understanding, disease or medication causing obesity or weight loss,
and participants in an alternative weight management program will not be included in
the study.
- Subjects with impaired glucose tolerance will not be excluded from participation.
- Non-English speaking subjects will not be excluded.
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