ObesityNCT03028233
Healthy Kids & Families: Overcoming Social, Environmental and Family Barriers to Childhood Obesity Prevention
A study testing Healthy Lifestyle and Positive Parenting in people with Obesity, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention. Barriers include social, environmental, and family issues. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Healthy Lifestyle and Positive Parenting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 22 Apr 2019
- 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 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Eligible individuals for the research study are parents/guardians and their K-6th grade children attending one of 9 schools in the greater Worcester area. Parents and their children are recruited as parent-child dyads.
Who cannot join
- Has an inability or unwillingness to give informed consent or assent
- Is a prisoner
- The child has been told by a doctor that they cannot walk or eat fruits and vegetables.
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Medical School
Worcester, Massachusetts, 01655
About this study
The study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention. Barriers include social, environmental, and family issues.
This intervention will be compared to a control condition consisting of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.
Read the detailed description
The study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention. Barriers include social, environmental, and family issues.
This intervention will be compared to a control condition consisting of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.
The intervention uses multiple delivery modalities to maintain novelty and prevent attrition/burden. These include home visits, telephone contacts, print (literacy sensitive newsletters), social media (Facebook), and community events. Parents and children will complete scheduled assessments at baseline, 6-, 12-, 18- and 24-month follow-up.
The Specific Aims are:
Aim 1: To determine the effectiveness of the intervention compared to the control condition on child physical activity, healthy eating, BMI and utilization of built environment resources.
Aim 2: To determine the effectiveness of the intervention compared to the control condition on parent physical activity, healthy eating, BMI.
Aim 3: To examine the potential scalability of the intervention guided by the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) model.
- Conditions
- Obesity
- Being tested
- Healthy Lifestyle, Positive Parenting
- Keywords
- physical activity, healthy eating, weight, families, Community Health Worker, childhood obesity, built environment
- Medical subject headings
- Obesity, Motor Activity, Body Weight, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy LifestyleBehavioural
A Community Health Worker coaches families regarding healthy eating, physical activity, and obesity prevention, and promotes the use of existing built environment resources.
Positive ParentingBehavioural
A Community Health Worker coaches parents on improving positive parenting skills and promotes the use of relevant community resources.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Lifestyles | Experimental | The study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention. Barriers include social, environmental, and family issues. Receives: Behavioral: Healthy Lifestyle |
| Positive Parenting | Active comparator | The control condition consists of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills. Receives: Behavioral: Positive Parenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
child BMI z-score
Weight and height is measured using standard methodology, with children wearing light clothing and no shoes. Weight is measured to the nearest 0.5 lb on a digital scale. Height is measured to the nearest tenth of a centimeter using a stadiometer. BMI is calculated: weight (kg)/height squared (meters) for age and gender using United States Centers for Disease Control and Prevention BMI charts growth charts.
Measured: 2 years
Secondary outcomes (14)
Child Dietary Behaviors: Overall
This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
Measured: 2 years
Child Dietary Behaviors for snacks
This Outcome Measure is assessed through the following measure, modified for verbal administration:Snack items from the Beverage and Snack Questionnaire2 (BSQ2) (https://sharedresources.fredhutch.org/documents/beverage-and-snack-questionnaire-2)
Measured: 2 years
Child Dietary Behaviors for Beverages
This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)
Measured: 2 years
Parent Dietary Behaviors: Overall
This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
Measured: 2 years
Parent Dietary Behaviors for Snacks
This Outcome Measure is assessed through the following measure, modified for verbal administration: Snack items from the Beverage and Snack Questionnaire2 (BSQ2) (https://sharedresources.fredhutch.org/documents/beverage-and-snack-questionnaire-2)
Measured: 2 years
Parent Dietary Behaviors for Beverages
This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)
Measured: 2 years
Child Physical Activity and Sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey
This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
Measured: 2 years
Child Physical Activity and Sedentariness: C-PAQ and PAQ-C
This Outcome Measure is assessed through the following measure, modified for verbal administration:Selected items from the Physical Activity C-PAQ (Kemper et al) plus PAQ-C (Kowalski et al) activity questions
Measured: 2 years
Child Physical Activity and Sedentariness: ActiGraph GT1M
Child physical activity and sedentariness are measured by the child wearing the ActiGraph Model GT1M for 7 days averaged. This measure provides data on intensity and duration of activities.
Measured: 2 years
Parent physical activity and sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey
This Outcome Measure is assessed through the following measure, modified for verbal administration:Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
Measured: 2 years
Parent physical activity and sedentariness: C-PAQ and PAQ-C
This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Physical Activity C-PAQ (Kemper et al) plus PAQ-C (Kowalski et al) activity questions
Measured: 2 years
Parent physical activity and sedentariness: ActiGraph GT1M
Parent physical activity and sedentariness are measured by the parent wearing the ActiGraph Model GT1M for 7 days averaged. This measure provides data on intensity and duration of activities
Measured: 2 years
Parent BMI
BMI is calculated with weight and height measurements using standard methodology. Weight is measured to the nearest 0.5 lb on a digital scale. Height is measured to the nearest centimeter using a stadiometer. BMI is calculated: weight (kg)/height squared (meters) for gender using United States Centers for Disease Control and Prevention BMI charts.
Measured: 2 years
Child utilization of built environment resources
Child utilization of built environment resources is assessed by the children wearing a portable GPS unit (~size of a matchbox) when wearing an accelerometer. The GPS unit records the geographic coordinates of the child's activities. Measures of frequency and duration of activities by neighborhood space (e.g., parks) can be ascertained.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startSep 2014
- Primary completion22 Apr 2019
- Study completion22 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Oak Hill Community Development Corporation, Worcester Public Schools
- Responsible party
- Principal investigator, Milagros Rosal, University of Massachusetts, Worcester
- Investigators
- Milagros C Rosal, PhD, Principal investigator, UMass Medical SchoolWenjun Li, PhD, Principal investigator, UMass Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028233
- Sponsor's protocol ID
- H00005048
- Other IDs
- U48DP005031
- Status last verified
- May 2019
- First submitted
- 10 Jan 2017
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borg A, Haughton CF, Sawyer M, Lemon SC, Kane K, Pbert L, Li W, Rosal MC. Design and methods of the Healthy Kids & Families study: a parent-focused community health worker-delivered childhood obesity prevention intervention. BMC Obes. 2019 Jun 3;6:19. doi: 10.1186/s40608-019-0240-x. eCollection 2019.
PubMed 31171975
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Kids & Families: Overcoming Social, Environmental and Family Barriers to Childhood Obesity Prevention
- ClinicalTrials.gov ID
- NCT03028233
- Acronym / sponsor ID
- H00005048
- Conditions
- Obesity
- Keywords
- physical activity, healthy eating, weight, families, Community Health Worker, childhood obesity, built environment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Oak Hill Community Development Corporation, Worcester Public Schools
- Study start
- Sep 2014
- Primary completion
- 22 Apr 2019 (actual)
- Study completion
- 22 Apr 2019 (actual)
- First posted
- 23 Jan 2017 (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 study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention. Barriers include social, environmental, and family issues.
This intervention will be compared to a control condition consisting of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.
Detailed description
The study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention. Barriers include social, environmental, and family issues.
This intervention will be compared to a control condition consisting of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.
The intervention uses multiple delivery modalities to maintain novelty and prevent attrition/burden. These include home visits, telephone contacts, print (literacy sensitive newsletters), social media (Facebook), and community events. Parents and children will complete scheduled assessments at baseline, 6-, 12-, 18- and 24-month follow-up.
The Specific Aims are:
Aim 1: To determine the effectiveness of the intervention compared to the control condition on child physical activity, healthy eating, BMI and utilization of built environment resources.
Aim 2: To determine the effectiveness of the intervention compared to the control condition on parent physical activity, healthy eating, BMI.
Aim 3: To examine the potential scalability of the intervention guided by the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) model.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Lifestyles | Experimental | Behavioral: Healthy LifestyleThe study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention. Barriers include social, environmental, and family issues. |
| Positive Parenting | Active comparator | Behavioral: Positive ParentingThe control condition consists of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible individuals for the research study are parents/guardians and their K-6th grade children attending one of 9 schools in the greater Worcester area. Parents and their children are recruited as parent-child dyads.
Key exclusion criteria (3 listed)
- Has an inability or unwillingness to give informed consent or assent
- Is a prisoner
- The child has been told by a doctor that they cannot walk or eat fruits and vegetables.
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 |
|---|---|---|
| Healthy LifestyleA Community Health Worker coaches families regarding healthy eating, physical activity, and obesity prevention, and promotes the use of existing built environment resources. | Behavioural | Healthy Lifestyles |
| Positive ParentingA Community Health Worker coaches parents on improving positive parenting skills and promotes the use of relevant community resources. | Behavioural | Positive Parenting |
Primary outcome
child BMI z-score
Time frame: 2 years
Weight and height is measured using standard methodology, with children wearing light clothing and no shoes. Weight is measured to the nearest 0.5 lb on a digital scale. Height is measured to the nearest tenth of a centimeter using a stadiometer. BMI is calculated: weight (kg)/height squared (meters) for age and gender using United States Centers for Disease Control and Prevention BMI charts growth charts.
14 secondary outcomes
Child Dietary Behaviors: Overall
Time frame: 2 years
Child Dietary Behaviors for snacks
Time frame: 2 years
Child Dietary Behaviors for Beverages
Time frame: 2 years
Parent Dietary Behaviors: Overall
Time frame: 2 years
Parent Dietary Behaviors for Snacks
Time frame: 2 years
Parent Dietary Behaviors for Beverages
Time frame: 2 years
Child Physical Activity and Sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey
Time frame: 2 years
Child Physical Activity and Sedentariness: C-PAQ and PAQ-C
Time frame: 2 years
Child Physical Activity and Sedentariness: ActiGraph GT1M
Time frame: 2 years
Parent physical activity and sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey
Time frame: 2 years
Parent physical activity and sedentariness: C-PAQ and PAQ-C
Time frame: 2 years
Parent physical activity and sedentariness: ActiGraph GT1M
Time frame: 2 years
Parent BMI
Time frame: 2 years
Child utilization of built environment resources
Time frame: 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 2019.
- Derived from this study: PubMed 31171975Borg A, Haughton CF, Sawyer M, Lemon SC, Kane K, Pbert L, Li W, Rosal MC. Design and methods of the Healthy Kids & Families study: a parent-focused community health worker-delivered childhood obesity prevention intervention. BMC Obes. 2019 Jun 3;6:19. doi: 10.1186/s40608-019-0240-x. eCollection 2019.
- Individual participant dataSharing planned: No
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.
Milagros C Rosal, PhD principal investigator
UMass Medical School
Wenjun Li, PhD principal investigator
UMass Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Lifestyle and Positive Parenting in people with Obesity, run by University of Massachusetts, Worcester 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 1 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 3 May 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?
child BMI z-score (time frame: 2 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 NCT03028233, which also lists 1 linked publication.
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 2019.