ObesityNCT01840631
A Trial To Study The Effects Of Group Versus Individual Dietary Counseling In Pediatric Obesity
A study testing Nutritional Counseling in people with Obesity, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Obesity
- What is being tested?
- Nutritional Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine West Campus CRC
The Bronx, New York, 10467
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Obesity
- Being tested
- Nutritional Counseling
- Keywords
- Obesity, Nutritional counseling, Physical activity, Food diary
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group nutritional counseling | Active comparator | In this arm, the Nutritionist will conduct the nutritional counseling with numerous patient families as a group Receives: Behavioral: Nutritional Counseling |
| Individual nutritional counseling | Active comparator | In this arm the nutritionist conducts the nutritional counseling with one patient family at a time Receives: Behavioral: Nutritional Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change I Mean Body Mass Index
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.
Measured: Baseline, month 6
Secondary outcomes (3)
Change in BMI with diet
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.
Measured: Baseline, month 6
Change in BMI with physical activity
The study will assess if there is a change in BMI with increased physical activity
Measured: Baseline, month 6
Change in BMI with metabolic profile
Study will assess if the change in BMI affects Metabolic profile of the subject.
Measured: Baseline, month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startApr 2013
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Underland, Albert Einstein College of Medicine
- Investigators
- Lisa Underland, MD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840631
- Sponsor's protocol ID
- 2012-214
- Status last verified
- Oct 2018
- First submitted
- 8 Mar 2013
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial To Study The Effects Of Group Versus Individual Dietary Counseling In Pediatric Obesity
- ClinicalTrials.gov ID
- NCT01840631
- Acronym / sponsor ID
- 2012-214
- Conditions
- Obesity
- Keywords
- Obesity, Nutritional counseling, Physical activity, Food diary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 26 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group nutritional counseling | Active comparator | Behavioral: Nutritional CounselingIn this arm, the Nutritionist will conduct the nutritional counseling with numerous patient families as a group |
| Individual nutritional counseling | Active comparator | Behavioral: Nutritional CounselingIn this arm the nutritionist conducts the nutritional counseling with one patient family at a time |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional CounselingParticipants 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. | Behavioural | Group nutritional counseling, Individual nutritional counseling |
Primary outcome
Change I Mean Body Mass Index
Time frame: 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.
3 secondary outcomes
Change in BMI with diet
Time frame: Baseline, month 6
Change in BMI with physical activity
Time frame: Baseline, month 6
Change in BMI with metabolic profile
Time frame: Baseline, month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Underland, MD principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Counseling in people with Obesity, run by Albert Einstein College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change I Mean Body Mass Index (time frame: Baseline, month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.