ObesityNCT02425046
Family Obesity Intervention: Motivational Interviewing and Community Support
A study testing health coaching and community screening in people with Obesity, run by Helena Laroche at 3 sites in United States.
Trial summary
Low-income children and children of obese parents are at high risk of obesity. Effective interventions are needed to target these families to improve the health of the parents and prevent obesity in the children. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- health coaching and community screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Mar 2015to 2 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- one parent must have a BMI of 30 or above, and be parent or guardian of at least one child
- between the ages of 6 and 12. Children this age are targeted because they benefit most from parental involvement
- are old enough to participate in family goal setting and activities, but young enough to be heavily influenced by family environment.
- a child must live with the obese parent at least 80% of the time.
Who cannot join
- adults with obesity or target children with a medical condition or medication that significantly alters their
- ability to follow the dietary recommendations (e.g., renal diet, severe food allergy, celiac disease)
- mobility (e.g. bed bound or unable to participate in any sort of physical activity even with assistive devices), or
- weight
- additionally we will exclude those who have a significant psychiatric disease, substance abuse disorder or cognitive impairment that would interfere with their ability to participate
- those with controlled or mild depression would not be excluded
Show all 12Show fewer
- adults with hypertension, type II diabetes, or glucose intolerance will not be excluded, as advocated changes are consistent with their needs
- no data will be collected from non-target children who meet the exclusion criteria.
- adults with obesity who are currently pregnant at baseline will be excluded because of their altered weight and dietary patterns. If the adult with obesity becomes pregnant during the intervention their family will be allowed to continue in the intervention but the pregnant adults' anthropometric data will not be collected.
- the intervention will intentionally target low-income families through recruitment site choices but will not exclude or include families based on income requirements.
- pregnant women will not be targeted but may be included if not the adult with obesity (see above).
- weight, height, waist circumference will not be collected on pregnant women.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Primary Health Care, Inc
Des Moines, Iowa, 50314
DMARC food pantries
Des Moines, Iowa, 50316
University of Iowa
Iowa City, Iowa, 52242
About this study
Low-income children and children of obese parents are at high risk of obesity. Effective interventions are needed to target these families to improve the health of the parents and prevent obesity in the children. The hypothesis is that an intervention that combines engagement of community organizations, motivational interviewing (MI, a technique proven to help people set goals that are personally meaningful), and resource mobilization will change diet and physical activity habits among disadvantaged families. This proposal grew from an established community-based participatory research (CBPR) partnership between the research team and community organizations that serve high minority (45-55%), low-income populations. Partners include a community health center, a food pantry network, a work-force training program, and other agencies. These partners designed and implemented a successful pilot project on which this proposal is based. The specific aims of this proposal are 1) To evaluate the efficacy of a family-targeted obesity intervention based on MI and resource-mobilization. Hypotheses: In comparison to control families, families participating in the intervention will demonstrate a) a reduction in BMI for adults, b) an increase in minutes of moderate physical activity and decreased sedentary time for both adults and children accelerometer), and c) a reduction in the number of obesity risk behaviors and an increase in obesity prevention behaviors among children. 2) To examine the mediators of intervention effects. 3) Identify the types of resources needed most often by intervention families to support lifestyle change. This randomized controlled trial includes 260 low-income families that contain at least one obese adult and one normal or overweight child between 6 and 12. The 12-month intervention has two elements. 1) A health coach will use MI to help families explore ambivalence toward and motivations for change and set goals for improving diet and physical activity. 2) To support goals, families will be connected with community agencies that can assist with general (e.g., financial) and goal specific resources (e.g., food, physical activity opportunities). Collaboration between organizations will streamline referrals, maximize resources, and facilitate access. Control families will get a basic screen for needs and information about available community resources. Outcomes are measured at baseline, 6, 12, and 18 months. This intervention is innovative in that it 1) focuses on lifestyle changes for the entire family and measures outcomes in adults and children, 2) combines MI focused on the entire family and community resource referrals specific to family needs and goals for change, 3) partners community organizations to coordinate resources for families, and 4) involves partners in all research phases via a CBPR approach. This contribution will be significant because the proposed intervention, if successful, can be replicated elsewhere and adapted to the local resource environment to address adult obesity and prevent childhood obesity in a high-risk population. The study will also identify the types of resources low-income families need to change diet and physical activity.
- Conditions
- Obesity
- Being tested
- health coaching, community screening
- Keywords
- family
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health coachingBehavioural
Health coaching using motivational interviewing focus on family diet and exercise change and connection with community resources specific to goals set.
community screeningBehavioural
Screening for community resources that families may be eligible for to receive help with basic needs including shelter, food, health insurance etc.
| Study group | Role | What they receive |
|---|---|---|
| health coaching and community screening | Experimental | Family Health Coaching and community benefits screening Receives: Behavioral: health coaching; Behavioral: community screening |
| community screening | Other | community benefits screening only Receives: Behavioral: community screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adult Body Mass Index
Change in Adult BMI from baseline to 12 months
Measured: Outcome was assessed at baseline and 12 months and then calculated by subtracting the baseline value from the value at 12 months
Change From Baseline in Duration of Daily Moderate to Vigorous Physical Activity
Moderate to vigorous physical activity of the target adult measure by an accelerometer at baseline and 12 months. Calculated by subtracting the baseline amount from the 12 month value. The accelerometer is a wrist worn device - worn for 7 days - which measures motion in three directions - the amount of motion is then used assess what level of physical activity the participant is doing at each time interval. Vigorous - such as running, moderate such as fast walking, light such as walking slowly.
Measured: measured at baseline and 12 months - outcome is the change from baseline to 12 months.
Change in Score for Target Child Over 12months on the Family Nutrition and Physical Activity Scale
Change in the Family Nutrition and Physical Activity Scale from baseline to 12 months - measure of behaviors relate to childhood obesity - parent reports for the target child. Scale scores possible range from 20 to 80. Higher indicates healthier behaviors.
Measured: measured at baseline and 12 months
Target Child - Change in Daily Moderate to Vigorous Physical Activity
Change in minutes per day of moderate to vigorous physical activity of the target child as measure by accelerometer from baseline to 12 months. Calculated by subtracting the baseline amount from the 12 month value. The accelerometer is a wrist worn device - worn for 7 days - which measures motion in three directions - the amount of motion is then used assess what level of physical activity the participant is doing at each time interval. Vigorous - such as running, moderate such as fast walking, light such as walking slowly.
Measured: baseline and 12 months
Secondary outcomes (6)
Adult - Change From Baseline in Number of 12 Ounce Cups or Cans Per Day of Sugar Sweetened Beverages
Change in self-reported sugar-sweetened beverage intake per day from baseline to 12 months as reported by participant in numbers of 12 ounce cups or cans.
Measured: baseline and 12 months
Adult - Physical Activity Questionnaires:
Reported leisure activity time on the Global Physical Activity Questionnaire reported in minutes per day.
Measured: 12 month
Adult - Waist Circumference:
waist circumference in centimeters
Measured: 12 months
Child - BMI Z-score:
Change in child BMI z-score from baseline to 12 months. The BMI z-score (BMIz) indicates the number of standard deviations away from the mean BMI for age and sex as determined by the CDC growth curves. A z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.
Measured: 12 months
Child - Screen Time Questionnaire:
total hours of screen time per week as collected by questionnaire given to the parent
Measured: 12 months
Child -Dietary Measures: Change in 12 Ounce Cups Per Day of Sugar Sweetened Beverages
Change in parent reported sugar-sweetened beverage intake per day from baseline to 12 months as reported per 12 ounce cup or can. Calculate by subtracting the baseline value from the 12 month value.
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study start26 Mar 2015
- Primary completion9 Oct 2018
- Study completion2 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helena Laroche
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Helena Laroche, University of Iowa
- Investigators
- helena Laroche, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425046
- Sponsor's protocol ID
- 201406722
- Status last verified
- May 2023
- First submitted
- 11 Dec 2014
- Last updated
- 5 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Investigator will contact PI to discuss their interest in using the data to learn about what is available - data dictionary (code book) of variable names may be made available. Investigator must complete a form outlining what analysis they are proposing. Investigator must sign a confidentiality agreement. Data provided in de-identified format and must be destroyed after analysis and publication is complete.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Obesity Intervention: Motivational Interviewing and Community Support
- ClinicalTrials.gov ID
- NCT02425046
- Acronym / sponsor ID
- 201406722
- Conditions
- Obesity
- Keywords
- family
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- Helena LarocheUniversity, hospital or other
- Study start
- 26 Mar 2015 (actual)
- Primary completion
- 9 Oct 2018 (actual)
- Study completion
- 2 Jul 2020 (actual)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Posted 5 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low-income children and children of obese parents are at high risk of obesity. Effective interventions are needed to target these families to improve the health of the parents and prevent obesity in the children. The hypothesis is that an intervention that combines engagement of community organizations, motivational interviewing (MI, a technique proven to help people set goals that are personally meaningful), and resource mobilization will change diet and physical activity habits among disadvantaged families. This proposal grew from an established community-based participatory research (CBPR) partnership between the research team and community organizations that serve high minority (45-55%), low-income populations. Partners include a community health center, a food pantry network, a work-force training program, and other agencies. These partners designed and implemented a successful pilot project on which this proposal is based. The specific aims of this proposal are 1) To evaluate the efficacy of a family-targeted obesity intervention based on MI and resource-mobilization. Hypotheses: In comparison to control families, families participating in the intervention will demonstrate a) a reduction in BMI for adults, b) an increase in minutes of moderate physical activity and decreased sedentary time for both adults and children accelerometer), and c) a reduction in the number of obesity risk behaviors and an increase in obesity prevention behaviors among children. 2) To examine the mediators of intervention effects. 3) Identify the types of resources needed most often by intervention families to support lifestyle change. This randomized controlled trial includes 260 low-income families that contain at least one obese adult and one normal or overweight child between 6 and 12. The 12-month intervention has two elements. 1) A health coach will use MI to help families explore ambivalence toward and motivations for change and set goals for improving diet and physical activity. 2) To support goals, families will be connected with community agencies that can assist with general (e.g., financial) and goal specific resources (e.g., food, physical activity opportunities). Collaboration between organizations will streamline referrals, maximize resources, and facilitate access. Control families will get a basic screen for needs and information about available community resources. Outcomes are measured at baseline, 6, 12, and 18 months. This intervention is innovative in that it 1) focuses on lifestyle changes for the entire family and measures outcomes in adults and children, 2) combines MI focused on the entire family and community resource referrals specific to family needs and goals for change, 3) partners community organizations to coordinate resources for families, and 4) involves partners in all research phases via a CBPR approach. This contribution will be significant because the proposed intervention, if successful, can be replicated elsewhere and adapted to the local resource environment to address adult obesity and prevent childhood obesity in a high-risk population. The study will also identify the types of resources low-income families need to change diet and physical activity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| health coaching and community screening | Experimental | Behavioral: health coaching, Behavioral: community screeningFamily Health Coaching and community benefits screening |
| community screening | Other | Behavioral: community screeningcommunity benefits screening only |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- one parent must have a BMI of 30 or above, and be parent or guardian of at least one child
- between the ages of 6 and 12. Children this age are targeted because they benefit most from parental involvement
- are old enough to participate in family goal setting and activities, but young enough to be heavily influenced by family environment.
- a child must live with the obese parent at least 80% of the time.
Key exclusion criteria (12 listed)
- adults with obesity or target children with a medical condition or medication that significantly alters their
- additionally we will exclude those who have a significant psychiatric disease, substance abuse disorder or cognitive impairment that would interfere with their ability to participate
- those with controlled or mild depression would not be excluded
- adults with hypertension, type II diabetes, or glucose intolerance will not be excluded, as advocated changes are consistent with their needs
- no data will be collected from non-target children who meet the exclusion criteria.
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 |
|---|---|---|
| health coachingHealth coaching using motivational interviewing focus on family diet and exercise change and connection with community resources specific to goals set. | Behavioural | health coaching and community screening |
| community screeningScreening for community resources that families may be eligible for to receive help with basic needs including shelter, food, health insurance etc. | Behavioural | community screening, health coaching and community screening |
Primary outcome
Change in Adult Body Mass Index
Time frame: Outcome was assessed at baseline and 12 months and then calculated by subtracting the baseline value from the value at 12 months
Change in Adult BMI from baseline to 12 months
Change From Baseline in Duration of Daily Moderate to Vigorous Physical Activity
Time frame: measured at baseline and 12 months - outcome is the change from baseline to 12 months.
Moderate to vigorous physical activity of the target adult measure by an accelerometer at baseline and 12 months. Calculated by subtracting the baseline amount from the 12 month value. The accelerometer is a wrist worn device - worn for 7 days - which measures motion in three directions - the amount of motion is then used assess what level of physical activity the participant is doing at each time interval. Vigorous - such as running, moderate such as fast walking, light such as walking slowly.
Change in Score for Target Child Over 12months on the Family Nutrition and Physical Activity Scale
Time frame: measured at baseline and 12 months
Change in the Family Nutrition and Physical Activity Scale from baseline to 12 months - measure of behaviors relate to childhood obesity - parent reports for the target child. Scale scores possible range from 20 to 80. Higher indicates healthier behaviors.
Target Child - Change in Daily Moderate to Vigorous Physical Activity
Time frame: baseline and 12 months
Change in minutes per day of moderate to vigorous physical activity of the target child as measure by accelerometer from baseline to 12 months. Calculated by subtracting the baseline amount from the 12 month value. The accelerometer is a wrist worn device - worn for 7 days - which measures motion in three directions - the amount of motion is then used assess what level of physical activity the participant is doing at each time interval. Vigorous - such as running, moderate such as fast walking, light such as walking slowly.
6 secondary outcomes
Adult - Change From Baseline in Number of 12 Ounce Cups or Cans Per Day of Sugar Sweetened Beverages
Time frame: baseline and 12 months
Adult - Physical Activity Questionnaires:
Time frame: 12 month
Adult - Waist Circumference:
Time frame: 12 months
Child - BMI Z-score:
Time frame: 12 months
Child - Screen Time Questionnaire:
Time frame: 12 months
Child -Dietary Measures: Change in 12 Ounce Cups Per Day of Sugar Sweetened Beverages
Time frame: baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Investigator will contact PI to discuss their interest in using the data to learn about what is available - data dictionary (code book) of variable names may be made available. Investigator must complete a form outlining what analysis they are proposing. Investigator must sign a confidentiality agreement. Data provided in de-identified format and must be destroyed after analysis and publication is complete.
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.
helena Laroche, MD principal investigator
University of Iowa
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing health coaching and community screening in people with Obesity, run by Helena Laroche at 3 sites 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 4 inclusion and 12 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 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 5 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Adult Body Mass Index (time frame: Outcome was assessed at baseline and 12 months and then calculated by subtracting the baseline value from the value at 12 months). The study lists 4 primary outcomes in all. 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 5 Feb 2024.