ObesityNCT02890056
A Community-based Study to Target Childhood Obesity
A study testing H2GO! in people with Obesity, run by Boston University at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy of a community-based behavioral intervention (H2GO!) on decreasing sugar-sweetened beverage consumption and promoting water consumption among school-aged youth and parents/caregivers. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- H2GO!
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to May 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
This study recruits parent/caregiver-child pairs. The inclusion and exclusion criteria are further specified based on parent/caregiver participants and child participants.
Child Inclusion Criteria:
- ages 9-12 years
- current member at the Boys and Girls Club study site
- able to understand and communicate in English
- able and willing to provide consent
- parental/caregiver permission to participate
Child Exclusion Criteria:
- medical condition that limits ability to change beverage consumption behaviors
Parent/Caregiver Inclusion Criteria:
- ages 18+ years
- parent/caregiver to a Boys and Girls Club child member
- able to understand and communicate in English
- able and willing to provide consent
Parent/Caregiver Exclusion Criteria:
- medical condition that limits ability to change beverage consumption behaviors
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University School of Pblic Health
Boston, Massachusetts, 02118
About this study
Official title: A Culturally-tailored Narrative Intervention to Target Disparities in Obesity
The purpose of this study is to determine the efficacy of a community-based behavioral intervention (H2GO!) on decreasing sugar-sweetened beverage consumption and promoting water consumption among school-aged youth and parents/caregivers. We hypothesize that participants in the intervention site will demonstrate reduced sugar-sweetened beverage intake intake and increased water intake compared to participants in the comparison site at 2 and 6 months follow-up.
Read the detailed description
This study aims to assess the efficacy of a community-based behavioral intervention (H2GO!) targeting sugar-sweetened beverage and water consumption among 108 parent-child pairs (N=216) through a site-randomized trial.
The study setting includes 2 Boys and Girls Club sites in Massachusetts, USA that were pair-matched for size and racial/ethnic composition. The Boys and Girls of America is a national organization that provides affordable after-school programs for a large population (~4 million annually) of diverse youth (33% White, 30% Black, 23% Latino) from predominantly low socioeconomic backgrounds through over 4,000 club facilities across the U.S.
The H2GO! intervention was designed to address two behavioral targets: reducing the number of sugar-sweetened beverage servings consumed per day (recommended guideline of zero servings per day) and promoting water consumption (approximately 5-8 cups per day for youth participants and 8 cups per day for parental participants). Informed by the Social Cognitive Theory and the Social Ecological Model, the H2GO! Intervention was designed to target child and parent participants' knowledge, attitudes (self-efficacy, outcome expectations, perceived social norms) and behavioral capabilities related to sugar-sweetened beverage and water consumption.
The 6-week behavioral intervention consists of group-based weekly sessions (1-hour sessions twice a week) delivered by trained Boys and Girls Club program staff at the Boys and Girls Club site. Each intervention session consists of a 1-hour health module followed by a 1-hour narrative module. Topics of the health modules include: understanding the benefits of water, sampling different types of fruit-flavored water, identifying sugar-sweetened beverages, exploring the local grocery store, identifying barriers and facilitators to drinking water, and managing triggers for sugar-sweetened beverages. The narrative modules include intervention objectives and activities that reinforce knowledge, attitudes, skills, and behaviors targeted in the previous health component.
Child participants will receive a reusable water bottle and a pictorial intervention booklet. Developed by the study principal investigator (PI) and research assistants, the brightly-colored booklet was culturally and linguistically-tailored to the study population and included intervention activity worksheets, parent-child take-home activities, fun facts and quizzes, and beverage consumption tracking sheets. Activity worksheets will be completed by participants during intervention sessions; and parent-child take-home activities will be completed following each session.
Study assessments will take place at baseline, 2 months, and 6 months.
- Conditions
- Obesity
- Being tested
- H2GO!
- Keywords
- sugar-sweetened beverage consumption, water consumption, dietary behaviors, youth
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H2GO!Behavioural
| Study group | Role | What they receive |
|---|---|---|
| H2GO! intervention | Experimental | H2GO! is a community-based behavioral intervention to reduce sugar-sweetened beverage consumption and promote water intake among school-age youth and parents.The intervention consists of 6 weekly group-based sessions (1-hour sessions twice a week) that target beverage knowledge, attitudes, and behaviors through interactive activities, youth-produced narratives, and parent-child activities. The intervention is delivered through a youth-based community setting (Boys and Girls Clubs of America) by trained Boys and Girls Club staff. Receives: Behavioral: H2GO! |
| Comparison | No intervention | Usual care will take place at the comparison site (standard programming at the Boys and Girls Club comparison site). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sugar-sweetened beverage consumption
Measured through self-report survey
Measured: Change from baseline to 6 months
Water consumption
Measured through self-report survey
Measured: Change from baseline to 6 months
Secondary outcomes (1)
Body mass index percentile (age- and sex-specific)
Trained staff will obtain child participants' height (inches) and weight (pounds) using standardized equipment. Height and weight will then be used to calculate body mass index (kg/m^2). Body mass index percentiles will be calculated using age- and sex-specific body mass index-based growth trajectories.
Measured: Change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Li-Sha Wang, Boston University
- Investigators
- Monica Wang, ScD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890056
- Sponsor's protocol ID
- H-34445
- Other IDs
- 1K01DK102447
- Status last verified
- Jun 2019
- First submitted
- 29 Aug 2016
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang ML, Otis M, Rosal MC, Griecci CF, Lemon SC. Reducing sugary drink intake through youth empowerment: results from a pilot-site randomized study. Int J Behav Nutr Phys Act. 2019 Jul 30;16(1):58. doi: 10.1186/s12966-019-0819-0.
PubMed 31362753Wang ML, Lemon SC, Clausen K, Whyte J, Rosal MC. Design and methods for a community-based intervention to reduce sugar-sweetened beverage consumption among youth: H2GO! study. BMC Public Health. 2016 Nov 9;16(1):1150. doi: 10.1186/s12889-016-3803-5.
PubMed 27829397
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Culturally-tailored Narrative Intervention to Target Disparities in Obesity
- ClinicalTrials.gov ID
- NCT02890056
- Acronym / sponsor ID
- H-34445
- Conditions
- Obesity
- Keywords
- sugar-sweetened beverage consumption, water consumption, dietary behaviors, youth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 7 Sep 2016 (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.
The purpose of this study is to determine the efficacy of a community-based behavioral intervention (H2GO!) on decreasing sugar-sweetened beverage consumption and promoting water consumption among school-aged youth and parents/caregivers. We hypothesize that participants in the intervention site will demonstrate reduced sugar-sweetened beverage intake intake and increased water intake compared to participants in the comparison site at 2 and 6 months follow-up.
Detailed description
This study aims to assess the efficacy of a community-based behavioral intervention (H2GO!) targeting sugar-sweetened beverage and water consumption among 108 parent-child pairs (N=216) through a site-randomized trial.
The study setting includes 2 Boys and Girls Club sites in Massachusetts, USA that were pair-matched for size and racial/ethnic composition. The Boys and Girls of America is a national organization that provides affordable after-school programs for a large population (~4 million annually) of diverse youth (33% White, 30% Black, 23% Latino) from predominantly low socioeconomic backgrounds through over 4,000 club facilities across the U.S.
The H2GO! intervention was designed to address two behavioral targets: reducing the number of sugar-sweetened beverage servings consumed per day (recommended guideline of zero servings per day) and promoting water consumption (approximately 5-8 cups per day for youth participants and 8 cups per day for parental participants). Informed by the Social Cognitive Theory and the Social Ecological Model, the H2GO! Intervention was designed to target child and parent participants' knowledge, attitudes (self-efficacy, outcome expectations, perceived social norms) and behavioral capabilities related to sugar-sweetened beverage and water consumption.
The 6-week behavioral intervention consists of group-based weekly sessions (1-hour sessions twice a week) delivered by trained Boys and Girls Club program staff at the Boys and Girls Club site. Each intervention session consists of a 1-hour health module followed by a 1-hour narrative module. Topics of the health modules include: understanding the benefits of water, sampling different types of fruit-flavored water, identifying sugar-sweetened beverages, exploring the local grocery store, identifying barriers and facilitators to drinking water, and managing triggers for sugar-sweetened beverages. The narrative modules include intervention objectives and activities that reinforce knowledge, attitudes, skills, and behaviors targeted in the previous health component.
Child participants will receive a reusable water bottle and a pictorial intervention booklet. Developed by the study principal investigator (PI) and research assistants, the brightly-colored booklet was culturally and linguistically-tailored to the study population and included intervention activity worksheets, parent-child take-home activities, fun facts and quizzes, and beverage consumption tracking sheets. Activity worksheets will be completed by participants during intervention sessions; and parent-child take-home activities will be completed following each session.
Study assessments will take place at baseline, 2 months, and 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| H2GO! intervention | Experimental | Behavioral: H2GO!H2GO! is a community-based behavioral intervention to reduce sugar-sweetened beverage consumption and promote water intake among school-age youth and parents.The intervention consists of 6 weekly group-based sessions (1-hour sessions twice a week) that target beverage knowledge, attitudes, and behaviors through interactive activities, youth-produced narratives, and parent-child activities. The intervention is delivered through a youth-based community setting (Boys and Girls Clubs of America) by trained Boys and Girls Club staff. |
| Comparison | No intervention | –Usual care will take place at the comparison site (standard programming at the Boys and Girls Club comparison site). |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 |
|---|---|---|
| H2GO! | Behavioural | H2GO! intervention |
Primary outcome
Sugar-sweetened beverage consumption
Time frame: Change from baseline to 6 months
Measured through self-report survey
Water consumption
Time frame: Change from baseline to 6 months
Measured through self-report survey
1 secondary outcome
Body mass index percentile (age- and sex-specific)
Time frame: Change from baseline to 6 months
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 Jun 2019.
- Derived from this study: PubMed 31362753Wang ML, Otis M, Rosal MC, Griecci CF, Lemon SC. Reducing sugary drink intake through youth empowerment: results from a pilot-site randomized study. Int J Behav Nutr Phys Act. 2019 Jul 30;16(1):58. doi: 10.1186/s12966-019-0819-0.
- Derived from this study: PubMed 27829397Wang ML, Lemon SC, Clausen K, Whyte J, Rosal MC. Design and methods for a community-based intervention to reduce sugar-sweetened beverage consumption among youth: H2GO! study. BMC Public Health. 2016 Nov 9;16(1):1150. doi: 10.1186/s12889-016-3803-5.
- Individual participant dataSharing planned: No
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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.
Monica Wang, ScD principal investigator
Boston 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 H2GO! in people with Obesity, run by Boston 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?
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 Jun 2019. 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?
Sugar-sweetened beverage consumption (time frame: Change from baseline to 6 months). The study lists 2 primary outcomes in all. 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 NCT02890056, which also lists 2 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 12 Jun 2019.