ObesityNCT01642836
Clinic, Family & Community Intervention for Children With Overweight and Obesity (Stanford GOALS)
A study testing MMM and Health and Nutrition Education in people with Obesity, run by Stanford University at 1 site in United States.
Trial summary
Stanford GOALS is a large-scale, community-based randomized controlled trial of an innovative, interdisciplinary, multi-component, multi-level, multi-setting (MMM) approach to treating overweight and obese children. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- MMM and Health and Nutrition Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2012to 19 Dec 2016
- 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 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 7-11 years of age
- BMI greater than or equal to the 85th percentile for age and sex on the 2000 U.S. Centers for Disease Control and Prevention (CDC) BMI reference
Who cannot join
- Have been diagnosed with a medical condition affecting growth (a genetic or metabolic disease/syndrome associated with obesity, Type 1 diabetes, Type 2 diabetes taking medication, chronic gastrointestinal diseases, Chronic renal diseases, uncorrected structural heart disease, heart failure, heart transplant, anorexia nervosa or bulimia nervosa or binge eating disorder (present or past), AIDS or HIV infection, pregnancy);
- Take medications affecting growth (systemic corticosteroids more than 2 weeks in the past year, insulin, oral hypoglycemics, thyroid hormone, growth hormone);
- Have a condition limiting their participation in the interventions (e.g., unable to participate in routine physical education classes at school, requiring oxygen supplementation for exertion, developmental or physical disability preventing participation in interventions, children or parents/guardians who cannot medically participate in mild dietary restrictions and/or increased physical activity for any reason);
- Have a condition limiting participation in the assessments (child or primary caregiver not able to read surveys in English or Spanish, child two or more grade levels delayed in school for reading and writing in her native language);
- Are unable to read, understand or complete informed consent in English or Spanish;
- Plan to move from the San Francisco Bay Area within the next 36 months.
- Are deemed to have another characteristic that makes them unsuitable for participation in the study in the judgment of the Principal Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinic, Family & Community Collaboration to Treat Overweight and Obese Children
Stanford GOALS is a large-scale, community-based randomized controlled trial of an innovative, interdisciplinary, multi-component, multi-level, multi-setting (MMM) approach to treating overweight and obese children. Primary Research Question: Will a 3-year, innovative, interdisciplinary, multi-component, multi-level, multi-setting (MMM) community-based intervention to treat overweight and obese children significantly reduce BMI compared to an enhanced standard care/health and nutrition education active comparison intervention?
Read the detailed description
Single-blind study with all outcomes assessors (data collectors) and Investigators masked (blinded) to intervention assignment. Intention-to-treat analysis.
- Conditions
- Obesity
- Being tested
- MMM, Health and Nutrition Education
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMMBehavioural
- a theory-based community team sports program designed specifically for overweight and obese children,
- a home-based family intervention to reduce screen time, alter the home food/eating environment, and promote self-regulatory skills for eating and activity behavior change, and
- a primary care provider behavioral counseling intervention linked to the community and home interventions.
Health and Nutrition EducationBehavioural
Enhanced standard care/health and nutrition education intervention:
- notification of primary care providers about metabolic measures and blood pressure
- state-of-the-art information-based health and nutrition education, including semi-annual home counseling visits, monthly health education newsletters for children and for parents/guardians, and a series of quarterly, community-based evening health lectures and "Family Fun Nights"
| Study group | Role | What they receive |
|---|---|---|
| multi-component, multi-level, multi-setting (MMM) | Experimental | 1. a theory-based community team sports program designed specifically for overweight and obese children,
2. a home-based family intervention to reduce screen time, alter the home food/eating environment, and promote self-regulatory skills for eating and activity behavior change, and
3. a primary care provider behavioral counseling intervention linked to the community and home interventions. Receives: Behavioral: MMM |
| Health and Nutrition Education | Active comparator | Enhanced standard care/health and nutrition education intervention:
1. notification of primary care providers about metabolic measures and blood pressure
2. state-of-the-art information-based health and nutrition education, including semi-annual home counseling visits, monthly health education newsletters for children and for parents/guardians, and a series of quarterly, community-based evening health lectures and "Family Fun Nights" Receives: Behavioral: Health and Nutrition Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
body mass index trajectory (change)
slope of measured weight in kilograms divided by the square of height in meters
Measured: baseline, 1, 2 and 3 years
Secondary outcomes (25)
waist circumference
waist circumference in centimeters
Measured: baseline, 1, 2 and 3 years
triceps skinfold thickness
triceps skinfold thickness in mm
Measured: baseline, 1, 2 and 3 years
Percent median BMI for age and sex (calculated from BMI)
age- and sex-adjusted BMI
Measured: baseline, 1, 2, and 3 years
Waist-to-Height Ratio
calculated from waist and height measures
Measured: baseline, 1, 2 and 3 years
Percent body fat (estimated)
Estimated from regression equation
Measured: baseline, 1, 2, and 3 years
fasting Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, Insulin, glucose, hemoglobin A1c, high sensitivity C-Reactive Protein, Alanine Aminotransferase (ALT)
lab assays of fasting samples
Measured: baseline, 1, 2 and 3 years
resting blood pressure
automated resting blood pressure
Measured: baseline, 1, 2 and 3 years
resting heart rate
automated pulse
Measured: baseline, 1, 2 and 3 years
physical activity measured by accelerometry
Actigraph model GT3X+ total and after school physical activity and sedentary behavior
Measured: baseline, 1, 2 and 3 years
screen time and other sedentary behaviors
self-reported weekday, saturday and sunday, television, movies, video games, computer, portable media devices, mobile phones
Measured: baseline, 1, 2 and 3 years
Typical household Television (TV) use
Constant TV household measure
Measured: baseline, 1, 2, and 3 years
Average total daily energy intake
from 24 hour diet recalls
Measured: baseline, 1, 2 and 3 years
Percent of energy intake from fat
from 24 hour diet recalls
Measured: baseline, 1, 2, and 3 years
Added sugar
from 24 hour diet recalls
Measured: baseline, 1, 2, and 3 years
Eating with screens
breakfast, dinner and energy (from 24-hour diet recalls)
Measured: baseline, 1, 2, and 3 years
Depressive symptoms
Children's Depression Index short form
Measured: baseline, 1, 2 and 3 years
Weight Concerns
Overconcern with weight and shape scale
Measured: baseline, 1, 2 and 3 years
School performance
parent/guardian reported grades
Measured: baseline, 1, 2 and 3 years
Children's sleep habits
parent/guardian reported
Measured: baseline, 1, 2 and 3 years
Implicit theories
fixed versus growth mindset
Measured: baseline, 1, 2, and 3 years
Parent/guardian weight
measured weight
Measured: baseline, 1, 2, and 3 years
Parent/guardian body mass index
calculated from measures of height and weight
Measured: baseline, 1, 2, and 3 years
Parent/guardian waist circumference
waist circumference measured in cm
Measured: baseline, 1, 2, and 3 years
Parent/guardian reported physical activity
survey
Measured: baseline, 1, 2, and 3 years
Parent/guardian health literacy
New Vital Sign (NVS) measure
Measured: baseline, 1 and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study start13 Jul 2012
- Primary completion19 Dec 2016
- Study completion19 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Thomas Robinson, Stanford University
- Investigators
- Thomas N Robinson, MD, MPH, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642836
- Sponsor's protocol ID
- 19311
- Other IDs
- U01HL103629
- Status last verified
- Apr 2021
- First submitted
- 10 Jul 2012
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Investigators can request the limited public access data set from the National Heart, Lung, and Blood Institute Biologic Specimen and Data Repository Information Coordinating Center
Publications
Robinson TN, Matheson D, Desai M, Wilson DM, Weintraub DL, Haskell WL, McClain A, McClure S, Banda JA, Sanders LM, Haydel KF, Killen JD. Family, community and clinic collaboration to treat overweight and obese children: Stanford GOALS-A randomized controlled trial of a three-year, multi-component, multi-level, multi-setting intervention. Contemp Clin Trials. 2013 Nov;36(2):421-35. doi: 10.1016/j.cct.2013.09.001. Epub 2013 Sep 10.
PubMed 24028942Robinson TN, Matheson D, Wilson DM, Weintraub DL, Banda JA, McClain A, Sanders LM, Haskell WL, Haydel KF, Kapphahn KI, Pratt C, Truesdale KP, Stevens J, Desai M. A community-based, multi-level, multi-setting, multi-component intervention to reduce weight gain among low socioeconomic status Latinx children with overweight or obesity: The Stanford GOALS randomised controlled trial. Lancet Diabetes Endocrinol. 2021 Jun;9(6):336-349. doi: 10.1016/S2213-8587(21)00084-X. Epub 2021 Apr 29.
PubMed 33933181JaKa MM, Wood C, Veblen-Mortenson S, Moore SM, Matheson D, Stevens J, Atkins L, Michie S, Adegbite-Adeniyi C, Olayinka O, Po'e EK, Kelly AM, Nicastro H, Bangdiwala SI, Barkin SL, Pratt C, Robinson TN, Sherwood NE. Applying the Behavior Change Technique Taxonomy to Four Multicomponent Childhood Obesity Interventions. West J Nurs Res. 2021 May;43(5):468-477. doi: 10.1177/0193945920954782. Epub 2020 Sep 10.
PubMed 32909523Truesdale KP, Matheson DM, JaKa MM, McAleer S, Sommer EC, Pratt CA. Baseline diet quality of predominantly minority children and adolescents from households characterized by low socioeconomic status in the Childhood Obesity Prevention and Treatment Research (COPTR) Consortium. BMC Nutr. 2019 Sep 9;5:38. doi: 10.1186/s40795-019-0302-y. eCollection 2019.
PubMed 32153951Cui Z, Truesdale KP, Robinson TN, Pemberton V, French SA, Escarfuller J, Casey TL, Hotop AM, Matheson D, Pratt CA, Lotas LJ, Po'e E, Andrisin S, Ward DS. Recruitment strategies for predominantly low-income, multi-racial/ethnic children and parents to 3-year community-based intervention trials: Childhood Obesity Prevention and Treatment Research (COPTR) Consortium. Trials. 2019 May 28;20(1):296. doi: 10.1186/s13063-019-3418-0.
PubMed 31138278
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinic, Family & Community Collaboration to Treat Overweight and Obese Children
- ClinicalTrials.gov ID
- NCT01642836
- Acronym / sponsor ID
- 19311
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 13 Jul 2012 (actual)
- Primary completion
- 19 Dec 2016 (actual)
- Study completion
- 19 Dec 2016 (actual)
- First posted
- 17 Jul 2012 (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.
Stanford GOALS is a large-scale, community-based randomized controlled trial of an innovative, interdisciplinary, multi-component, multi-level, multi-setting (MMM) approach to treating overweight and obese children. Primary Research Question: Will a 3-year, innovative, interdisciplinary, multi-component, multi-level, multi-setting (MMM) community-based intervention to treat overweight and obese children significantly reduce BMI compared to an enhanced standard care/health and nutrition education active comparison intervention?
Detailed description
Single-blind study with all outcomes assessors (data collectors) and Investigators masked (blinded) to intervention assignment. Intention-to-treat analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multi-component, multi-level, multi-setting (MMM) | Experimental | Behavioral: MMM1. a theory-based community team sports program designed specifically for overweight and obese children, 2. a home-based family intervention to reduce screen time, alter the home food/eating environment, and promote self-regulatory skills for eating and activity behavior change, and 3. a primary care provider behavioral counseling intervention linked to the community and home interventions. |
| Health and Nutrition Education | Active comparator | Behavioral: Health and Nutrition EducationEnhanced standard care/health and nutrition education intervention: 1. notification of primary care providers about metabolic measures and blood pressure 2. state-of-the-art information-based health and nutrition education, including semi-annual home counseling visits, monthly health education newsletters for children and for parents/guardians, and a series of quarterly, community-based evening health lectures and "Family Fun Nights" |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 7-11 years of age
- BMI greater than or equal to the 85th percentile for age and sex on the 2000 U.S. Centers for Disease Control and Prevention (CDC) BMI reference
Key exclusion criteria (7 listed)
- Have been diagnosed with a medical condition affecting growth (a genetic or metabolic disease/syndrome associated with obesity, Type 1 diabetes, Type 2 diabetes taking medication, chronic gastrointestinal diseases, Chronic renal diseases, uncorrected structural heart disease, heart failure, heart transplant, anorexia nervosa or bulimia nervosa or binge eating disorder (present or past), AIDS or HIV infection, pregnancy);
- Take medications affecting growth (systemic corticosteroids more than 2 weeks in the past year, insulin, oral hypoglycemics, thyroid hormone, growth hormone);
- Have a condition limiting their participation in the interventions (e.g., unable to participate in routine physical education classes at school, requiring oxygen supplementation for exertion, developmental or physical disability preventing participation in interventions, children or parents/guardians who cannot medically participate in mild dietary restrictions and/or increased physical activity for any reason);
- Have a condition limiting participation in the assessments (child or primary caregiver not able to read surveys in English or Spanish, child two or more grade levels delayed in school for reading and writing in her native language);
- Are unable to read, understand or complete informed consent in English or Spanish;
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 |
|---|---|---|
| MMM1. a theory-based community team sports program designed specifically for overweight and obese children, 2. a home-based family intervention to reduce screen time, alter the home food/eating environment, and promote self-regulatory skills for eating and activity behavior change, and 3. a primary care provider behavioral counseling intervention linked to the community and home interventions. | Behavioural | multi-component, multi-level, multi-setting (MMM) |
| Health and Nutrition EducationEnhanced standard care/health and nutrition education intervention: 1. notification of primary care providers about metabolic measures and blood pressure 2. state-of-the-art information-based health and nutrition education, including semi-annual home counseling visits, monthly health education newsletters for children and for parents/guardians, and a series of quarterly, community-based evening health lectures and "Family Fun Nights" | Behavioural | Health and Nutrition Education |
Primary outcome
body mass index trajectory (change)
Time frame: baseline, 1, 2 and 3 years
slope of measured weight in kilograms divided by the square of height in meters
25 secondary outcomes
waist circumference
Time frame: baseline, 1, 2 and 3 years
triceps skinfold thickness
Time frame: baseline, 1, 2 and 3 years
Percent median BMI for age and sex (calculated from BMI)
Time frame: baseline, 1, 2, and 3 years
Waist-to-Height Ratio
Time frame: baseline, 1, 2 and 3 years
Percent body fat (estimated)
Time frame: baseline, 1, 2, and 3 years
fasting Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, Insulin, glucose, hemoglobin A1c, high sensitivity C-Reactive Protein, Alanine Aminotransferase (ALT)
Time frame: baseline, 1, 2 and 3 years
resting blood pressure
Time frame: baseline, 1, 2 and 3 years
resting heart rate
Time frame: baseline, 1, 2 and 3 years
physical activity measured by accelerometry
Time frame: baseline, 1, 2 and 3 years
screen time and other sedentary behaviors
Time frame: baseline, 1, 2 and 3 years
Typical household Television (TV) use
Time frame: baseline, 1, 2, and 3 years
Average total daily energy intake
Time frame: baseline, 1, 2 and 3 years
Percent of energy intake from fat
Time frame: baseline, 1, 2, and 3 years
Added sugar
Time frame: baseline, 1, 2, and 3 years
Eating with screens
Time frame: baseline, 1, 2, and 3 years
Depressive symptoms
Time frame: baseline, 1, 2 and 3 years
Weight Concerns
Time frame: baseline, 1, 2 and 3 years
School performance
Time frame: baseline, 1, 2 and 3 years
Children's sleep habits
Time frame: baseline, 1, 2 and 3 years
Implicit theories
Time frame: baseline, 1, 2, and 3 years
Parent/guardian weight
Time frame: baseline, 1, 2, and 3 years
Parent/guardian body mass index
Time frame: baseline, 1, 2, and 3 years
Parent/guardian waist circumference
Time frame: baseline, 1, 2, and 3 years
Parent/guardian reported physical activity
Time frame: baseline, 1, 2, and 3 years
Parent/guardian health literacy
Time frame: baseline, 1 and 2 years
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 3 May 2021.
- Background: PubMed 24028942Robinson TN, Matheson D, Desai M, Wilson DM, Weintraub DL, Haskell WL, McClain A, McClure S, Banda JA, Sanders LM, Haydel KF, Killen JD. Family, community and clinic collaboration to treat overweight and obese children: Stanford GOALS-A randomized controlled trial of a three-year, multi-component, multi-level, multi-setting intervention. Contemp Clin Trials. 2013 Nov;36(2):421-35. doi: 10.1016/j.cct.2013.09.001. Epub 2013 Sep 10.
- Derived from this study: PubMed 33933181Robinson TN, Matheson D, Wilson DM, Weintraub DL, Banda JA, McClain A, Sanders LM, Haskell WL, Haydel KF, Kapphahn KI, Pratt C, Truesdale KP, Stevens J, Desai M. A community-based, multi-level, multi-setting, multi-component intervention to reduce weight gain among low socioeconomic status Latinx children with overweight or obesity: The Stanford GOALS randomised controlled trial. Lancet Diabetes Endocrinol. 2021 Jun;9(6):336-349. doi: 10.1016/S2213-8587(21)00084-X. Epub 2021 Apr 29.
- Derived from this study: PubMed 32909523JaKa MM, Wood C, Veblen-Mortenson S, Moore SM, Matheson D, Stevens J, Atkins L, Michie S, Adegbite-Adeniyi C, Olayinka O, Po'e EK, Kelly AM, Nicastro H, Bangdiwala SI, Barkin SL, Pratt C, Robinson TN, Sherwood NE. Applying the Behavior Change Technique Taxonomy to Four Multicomponent Childhood Obesity Interventions. West J Nurs Res. 2021 May;43(5):468-477. doi: 10.1177/0193945920954782. Epub 2020 Sep 10.
- Derived from this study: PubMed 32153951Truesdale KP, Matheson DM, JaKa MM, McAleer S, Sommer EC, Pratt CA. Baseline diet quality of predominantly minority children and adolescents from households characterized by low socioeconomic status in the Childhood Obesity Prevention and Treatment Research (COPTR) Consortium. BMC Nutr. 2019 Sep 9;5:38. doi: 10.1186/s40795-019-0302-y. eCollection 2019.
- Derived from this study: PubMed 31138278Cui Z, Truesdale KP, Robinson TN, Pemberton V, French SA, Escarfuller J, Casey TL, Hotop AM, Matheson D, Pratt CA, Lotas LJ, Po'e E, Andrisin S, Ward DS. Recruitment strategies for predominantly low-income, multi-racial/ethnic children and parents to 3-year community-based intervention trials: Childhood Obesity Prevention and Treatment Research (COPTR) Consortium. Trials. 2019 May 28;20(1):296. doi: 10.1186/s13063-019-3418-0.
- Individual participant dataSharing planned: Yes. Investigators can request the limited public access data set from the National Heart, Lung, and Blood Institute Biologic Specimen and Data Repository Information Coordinating Center
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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.
Thomas N Robinson, MD, MPH principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MMM and Health and Nutrition Education in people with Obesity, run by Stanford University 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 7 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 3 May 2021. 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?
body mass index trajectory (change) (time frame: baseline, 1, 2 and 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01642836, which also lists 5 linked publications.
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 3 May 2021.