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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| health coaching and community screening | Experimental | Family Health Coaching and community benefits screening |
|
| community screening | Other | community benefits screening only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| health coaching | Behavioral | Health coaching using motivational interviewing focus on family diet and exercise change and connection with community resources specific to goals set. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Adult Body Mass Index | Change in Adult BMI from baseline to 12 months | 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 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 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. | baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and 12 months |
| Adult - Physical Activity Questionnaires: |
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Inclusion Criteria:
Exclusion Criteria:
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.
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.
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| Name | Affiliation | Role |
|---|---|---|
| helena Laroche, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary Health Care, Inc | Des Moines | Iowa | 50314 | United States | ||
| DMARC food pantries |
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.
Available after 18-month data has been processed and cleaned. Estimated date: June 2020 (subject to change, dependent on COVID-19).
Form will be reviewed by the PI, University of Iowa investigative team and the community advisory board and a decision about approval will be made. A University of Iowa research team member must be included in the analysis team to help with context and interpretation of data.
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After baseline data collection, participants were not randomized until the were able to be contacted by phone by the community resource specialist who explained the randomization process again and provided them with their assignment. If participants were no longer able to be contacted or no longer wished to participate after baseline data collection they were not randomized.
Numbers reflect the total number of unique participants and not the number of dyads.
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| ID | Title | Description |
|---|---|---|
| FG000 | Health Coaching and Community Screening | Family Health Coaching and community benefits screening health coaching: Health coaching using motivational interviewing focus on family diet and exercise change and connection with community resources specific to goals set. community screening: Screening for community resources that families may be eligible for to receive help with basic needs including shelter, food, health insurance etc. Written information on healthy family diet and exercise |
| FG001 | Community Screening | community benefits screening only community screening: Screening for community resources that families may be eligible for to receive help with basic needs including shelter, food, health insurance etc. Written information on healthy family diet and exercise |
| FG002 | Lost to Follow up Before Randomization | Participants unable to be contacted after baseline and thus never randomized to an intervention group per protocol. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 208 adult-child pairs (416 participants) were randomized - baseline information is provided on them. The 28 adult-child pairs (56 participants) who were consented but who were not randomized (per protocol because of loss to follow up) are not included in these numbers.
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| ID | Title | Description |
|---|---|---|
| BG000 | Health Coaching and Community Screening | Family Health Coaching and community benefits screening health coaching: Health coaching using motivational interviewing focus on family diet and exercise change and connection with community resources specific to goals set. community screening: Screening for community resources that families may be eligible for to receive help with basic needs including shelter, food, health insurance etc. Written information on healthy family diet and exercise |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Adult Body Mass Index | Change in Adult BMI from baseline to 12 months | All adult participants who were randomized. | Posted | Mean | Standard Error | kg/m2 | Outcome was assessed at baseline and 12 months and then calculated by subtracting the baseline value from the value at 12 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Health Coaching and Community Screening | Family Health Coaching and community benefits screening health coaching: Health coaching using motivational interviewing focus on family diet and exercise change and connection with community resources specific to goals set. community screening: Screening for community resources that families may be eligible for to receive help with basic needs including shelter, food, health insurance etc. Written information on healthy family diet and exercise |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Helena Laroche | Center for Children's Healthy Lifestyles & Nutrition - Children's Mercy Hospital | (816) 234-9251 | hhlaroche@cmh.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 1, 2019 | Oct 20, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| community screening | Behavioral | Screening for community resources that families may be eligible for to receive help with basic needs including shelter, food, health insurance etc. |
|
Reported leisure activity time on the Global Physical Activity Questionnaire reported in minutes per day. |
| 12 month |
| Adult - Waist Circumference: | waist circumference in centimeters | 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. | 12 months |
| Child - Screen Time Questionnaire: | total hours of screen time per week as collected by questionnaire given to the parent | 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. | baseline and 12 months |
| Des Moines |
| Iowa |
| 50316 |
| United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| BG001 | Community Screening | community benefits screening only community screening: Screening for community resources that families may be eligible for to receive help with basic needs including shelter, food, health insurance etc. Written information on healthy family diet and exercise |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Education Level, Adults | Count of Participants | Participants |
|
| Diabetes Status (Adults) | Count of Participants | Participants |
|
| Family Income (before taxes), Adults | Mean | Standard Deviation | dollars |
|
| BMI, kg/m^2, Adults | Mean | Standard Deviation | kg/m^2 |
|
| BMI z-score (BMIz), Child | 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. | Mean | Standard Deviation | BMI z-score (BMIz) |
|
| Family Nutrition and Physical Activity Scale, Child | The Family Nutrition and Physical Activity Scale is a 20 item measure of family behaviors linked to childhood obesity either as protective behaviors or behaviors that promote obesity. Each question may contribute a score between from 1 to 4. Thus the potential score ranges from 20 to 80 and a higher score reflects fewer behaviors thought to contribute to obesity and more behaviors beneficial to obesity prevention. | Mean | Standard Deviation | Unit on a scale |
|
| OG001 |
| Community Screening |
community benefits screening only community screening: Screening for community resources that families may be eligible for to receive help with basic needs including shelter, food, health insurance etc. Written information on healthy family diet and exercise |
|
|
|
| Primary | 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. | All target adults randomized | Posted | Mean | Standard Error | minutes per day | measured at baseline and 12 months - outcome is the change from baseline to 12 months. |
|
|
|
|
| Primary | 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. | All target children randomized | Posted | Mean | Standard Error | units on a scale | measured at baseline and 12 months |
|
|
|
|
| Primary | 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. | All target children randomized | Posted | Mean | Standard Error | minutes per day | baseline and 12 months |
|
|
|
|
| Secondary | 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. | All randomized target adults | Posted | Mean | Standard Error | # of 12 ounce cups per day | baseline and 12 months |
|
|
|
|
| Secondary | Adult - Physical Activity Questionnaires: | Reported leisure activity time on the Global Physical Activity Questionnaire reported in minutes per day. | All randomized target adult participant who completed the GPAQ questionnaire. One participant removed for implausible value at baseline. Linear Mixed Models used all participants. | Posted | Mean | Standard Deviation | minutes per day | 12 month |
|
|
|
|
| Secondary | Adult - Waist Circumference: | waist circumference in centimeters | Every randomized participant with a valid waist circumference measurements at baseline was used in statistical analysis. For means reported below only those with data at 12 months are used 68 control and 65 intervention. | Posted | Mean | Standard Deviation | centimeters | 12 months |
|
|
|
|
| Secondary | 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. | All target children randomized | Posted | Mean | Standard Error | units on a scale | 12 months |
|
|
|
|
| Secondary | Child - Screen Time Questionnaire: | total hours of screen time per week as collected by questionnaire given to the parent | Randomized target/Index Child whose parents completed the screen time questionnaire at baseline. All data used for LQMM model. Means provided based only on those who completed the 12 month questionnaire - 71 control and 67 intervention | Posted | Mean | Standard Deviation | hours per week | 12 months |
|
|
|
|
| Secondary | 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. | All targeted children randomized | Posted | Mean | Standard Error | # of 12 ounce cups per day | baseline and 12 months |
|
|
|
|
| 0 |
| 103 |
| 0 |
| 103 |
| 0 |
| 103 |
| EG001 | Community Screening | community benefits screening only community screening: Screening for community resources that families may be eligible for to receive help with basic needs including shelter, food, health insurance etc. Written information on healthy family diet and exercise | 0 | 105 | 0 | 105 | 0 | 105 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|