A Trial To Study The Effects Of Group Versus Individual Dietary Counseling In Pediatric Obesity
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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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New York
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Bronx, New York, Förenta staterna, 10467
- Albert Einstein College of Medicine West Campus CRC
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Group nutritional counseling
In this arm, the Nutritionist will conduct the nutritional counseling with numerous patient families as a group
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Participants enrolled will be randomized into group nutrition counseling or individual nutrition counseling classes, for a total of 6 classes.
Classes will meet one time a month.
Classes will cover topics including nutrition, exercise, and behavior to promote healthy eating.
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Aktiv komparator: Individual nutritional counseling
In this arm the nutritionist conducts the nutritional counseling with one patient family at a time
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Participants enrolled will be randomized into group nutrition counseling or individual nutrition counseling classes, for a total of 6 classes.
Classes will meet one time a month.
Classes will cover topics including nutrition, exercise, and behavior to promote healthy eating.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change I Mean Body Mass Index
Tidsram: Baseline, month 6
|
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, investigators will compare the mean change in BMI after 6 months of intervention in the two study arms.
As per previous studies, it is expected the group intervention arm to achieve a mean BMI reduction of 0.8 +/- 1.4 greater than the control arm.
The study also posits that a difference in mean BMI change as low as 0.1 would be clinically equivalent.
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Baseline, month 6
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in BMI with diet
Tidsram: Baseline, month 6
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The secondary aim of the study is to determine if the change in BMI is associated with changes in the dietary composition.
All the secondary outcomes will be measured by Pearson correlation coefficients or multi-variable linear regression models as appropriate to calculate this.
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Baseline, month 6
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Change in BMI with physical activity
Tidsram: Baseline, month 6
|
The study will assess if there is a change in BMI with increased physical activity
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Baseline, month 6
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Change in BMI with metabolic profile
Tidsram: Baseline, month 6
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Study will assess if the change in BMI affects Metabolic profile of the subject.
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Baseline, month 6
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Lisa Underland, MD, Albert Einstein College Of Medicine
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2012-214
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