Obesity
Conditions
Keywords
family
Brief 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. 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.
Interventions
BEHAVIORALhealth coaching
Health coaching using motivational interviewing focus on family diet and exercise change and connection with community resources specific to goals set.
BEHAVIORALcommunity screening
Screening for community resources that families may be eligible for to receive help with basic needs including shelter, food, health insurance etc.
Sponsors
Helena Laroche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* adults with obesity or target children with a medical condition or medication that significantly alters their 1. ability to follow the dietary recommendations (e.g., renal diet, severe food allergy, celiac disease) 2. mobility (e.g. bed bound or unable to participate in any sort of physical activity even with assistive devices), or 3. 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Adult Body Mass Index | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child - Screen Time Questionnaire: | 12 months | total hours of screen time per week as collected by questionnaire given to the parent |
| Adult - Change From Baseline in Number of 12 Ounce Cups or Cans Per Day of Sugar Sweetened Beverages | baseline and 12 months | 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. |
| Child -Dietary Measures: Change in 12 Ounce Cups Per Day of Sugar Sweetened Beverages | baseline and 12 months | 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. |
| Adult - Physical Activity Questionnaires: | 12 month | Reported leisure activity time on the Global Physical Activity Questionnaire reported in minutes per day. |
| Adult - Waist Circumference: | 12 months | waist circumference in centimeters |
| Child - BMI Z-score: | 12 months | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 103 |
| 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 | 105 |
| Total | 208 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 52 | 50 | 56 |
| Overall Study | Withdrawal by Subject | 16 | 12 | 0 |
Baseline characteristics
| Characteristic | Community Screening | Total | Health Coaching and Community Screening |
|---|---|---|---|
| Age, Continuous Adult | 35.2 Years STANDARD_DEVIATION 7.1 | 35.1 Years STANDARD_DEVIATION 7.2 | 35.1 Years STANDARD_DEVIATION 7.1 |
| Age, Continuous Child | 8.8 Years STANDARD_DEVIATION 2 | 8.6 Years STANDARD_DEVIATION 1.9 | 8.4 Years STANDARD_DEVIATION 2 |
| BMI, kg/m^2, Adults | 39.7 kg/m^2 STANDARD_DEVIATION 7.2 | 39.4 kg/m^2 STANDARD_DEVIATION 7.35 | 39.1 kg/m^2 STANDARD_DEVIATION 7.1 |
| BMI z-score (BMIz), Child | 1.1 BMI z-score (BMIz) STANDARD_DEVIATION 1 | 1.1 BMI z-score (BMIz) STANDARD_DEVIATION 1.1 | 1.2 BMI z-score (BMIz) STANDARD_DEVIATION 1 |
| Diabetes Status (Adults) Diabetes | 8 Participants | 16 Participants | 8 Participants |
| Diabetes Status (Adults) Neither | 86 Participants | 173 Participants | 87 Participants |
| Diabetes Status (Adults) Prediabetes | 9 Participants | 14 Participants | 5 Participants |
| Diabetes Status (Adults) Unknown | 2 Participants | 5 Participants | 3 Participants |
| Education Level, Adults College Graduate | 28 Participants | 52 Participants | 24 Participants |
| Education Level, Adults High School Graduate | 51 Participants | 102 Participants | 51 Participants |
| Education Level, Adults High School Not Completed | 26 Participants | 53 Participants | 27 Participants |
| Education Level, Adults Unknown | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Adult Hispanic or Latino | 31 Participants | 56 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Adult Not Hispanic or Latino | 74 Participants | 151 Participants | 77 Participants |
| Ethnicity (NIH/OMB) Adult Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Family Income (before taxes), Adults | 26979 dollars STANDARD_DEVIATION 24818 | 28437 dollars STANDARD_DEVIATION 26189 | 29987 dollars STANDARD_DEVIATION 29503 |
| Family Nutrition and Physical Activity Scale, Child | 59.6 Unit on a scale STANDARD_DEVIATION 9.2 | 59.8 Unit on a scale STANDARD_DEVIATION 8.6 | 60.1 Unit on a scale STANDARD_DEVIATION 8.1 |
| Race (NIH/OMB) Adult American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adult Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adult Black or African American | 34 Participants | 66 Participants | 32 Participants |
| Race (NIH/OMB) Adult More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adult Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adult Unknown or Not Reported | 29 Participants | 57 Participants | 28 Participants |
| Race (NIH/OMB) Adult White | 42 Participants | 85 Participants | 43 Participants |
| Race (NIH/OMB) Child American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Child Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Child Black or African American | 34 Participants | 65 Participants | 31 Participants |
| Race (NIH/OMB) Child More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Child Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Child Unknown or Not Reported | 23 Participants | 48 Participants | 25 Participants |
| Race (NIH/OMB) Child White | 48 Participants | 95 Participants | 47 Participants |
| Sex: Female, Male Adult Female | 100 Participants | 198 Participants | 98 Participants |
| Sex: Female, Male Adult Male | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Child Female | 52 Participants | 100 Participants | 48 Participants |
| Sex: Female, Male Child Male | 53 Participants | 108 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 103 | 0 / 105 |
| other Total, other adverse events | 0 / 103 | 0 / 105 |
| serious Total, serious adverse events | 0 / 103 | 0 / 105 |
Outcome results
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.
Time frame: measured at baseline and 12 months - outcome is the change from baseline to 12 months.
Population: All target adults randomized
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching and Community Screening | Change From Baseline in Duration of Daily Moderate to Vigorous Physical Activity | -2.7 minutes per day | Standard Error 9 |
| Community Screening | Change From Baseline in Duration of Daily Moderate to Vigorous Physical Activity | 0.5 minutes per day | Standard Error 5.2 |
Comparison: null hypothesis - there will be no difference between the groups.p-value: 0.735t-test, 2 sided
Primary
Change in Adult Body Mass Index
Change in Adult BMI from baseline to 12 months
Time frame: Outcome was assessed at baseline and 12 months and then calculated by subtracting the baseline value from the value at 12 months
Population: All adult participants who were randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching and Community Screening | Change in Adult Body Mass Index | 0.3 kg/m2 | Standard Error 0.9 |
| Community Screening | Change in Adult Body Mass Index | -0.1 kg/m2 | Standard Error 0.7 |
p-value: 0.67t-test, 2 sided
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.
Time frame: measured at baseline and 12 months
Population: All target children randomized
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching and Community Screening | Change in Score for Target Child Over 12months on the Family Nutrition and Physical Activity Scale | 2.2 units on a scale | Standard Error 0.9 |
| Community Screening | Change in Score for Target Child Over 12months on the Family Nutrition and Physical Activity Scale | 2.8 units on a scale | Standard Error 1 |
Comparison: Null hypothesis that there would be no difference in change in FNPA scores between the two groups over 12 months.p-value: 0.599t-test, 2 sided
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.
Time frame: baseline and 12 months
Population: All target children randomized
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching and Community Screening | Target Child - Change in Daily Moderate to Vigorous Physical Activity | -7.0 minutes per day | Standard Error 3 |
| Community Screening | Target Child - Change in Daily Moderate to Vigorous Physical Activity | -9.6 minutes per day | Standard Error 3.3 |
Comparison: Null hypothesis: Change in MVPA from baseline to 12 months will not be different between target children in the two groups.p-value: 0.583t-test, 2 sided
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.
Time frame: baseline and 12 months
Population: All randomized target adults
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching and Community Screening | Adult - Change From Baseline in Number of 12 Ounce Cups or Cans Per Day of Sugar Sweetened Beverages | -0.6 # of 12 ounce cups per day | Standard Error 0.4 |
| Community Screening | Adult - Change From Baseline in Number of 12 Ounce Cups or Cans Per Day of Sugar Sweetened Beverages | -1.3 # of 12 ounce cups per day | Standard Error 0.4 |
Comparison: Null hypothesis is that there will be no difference between the two arms in change in sugar sweetened beverage intake over 12 months.p-value: 0.312t-test, 2 sided
Secondary
Adult - Physical Activity Questionnaires:
Reported leisure activity time on the Global Physical Activity Questionnaire reported in minutes per day.
Time frame: 12 month
Population: All randomized target adult participant who completed the GPAQ questionnaire. One participant removed for implausible value at baseline. Linear Mixed Models used all participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching and Community Screening | Adult - Physical Activity Questionnaires: | 120 minutes per day | Standard Deviation 188 |
| Community Screening | Adult - Physical Activity Questionnaires: | 100 minutes per day | Standard Deviation 193 |
Comparison: Linear quantile mixed models (a non-parametric linear mixed model) was used because because of non-normal distribution that could not be remedied by transformation.p-value: 0.195% CI: [-15, 165]Linear quantile mixed model
Secondary
Adult - Waist Circumference:
waist circumference in centimeters
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching and Community Screening | Adult - Waist Circumference: | 114.3 centimeters | Standard Deviation 13.8 |
| Community Screening | Adult - Waist Circumference: | 119.7 centimeters | Standard Deviation 14.9 |
p-value: 0.05795% CI: [-5.14, 0.07]Mixed Models Analysis
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.
Time frame: 12 months
Population: All target children randomized
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching and Community Screening | Child - BMI Z-score: | 0.0 units on a scale | Standard Error 0.04 |
| Community Screening | Child - BMI Z-score: | 0.0 units on a scale | Standard Error 0 |
p-value: 0.874t-test, 2 sided
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.
Time frame: baseline and 12 months
Population: All targeted children randomized
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching and Community Screening | Child -Dietary Measures: Change in 12 Ounce Cups Per Day of Sugar Sweetened Beverages | -0.5 # of 12 ounce cups per day | Standard Error 0.2 |
| Community Screening | Child -Dietary Measures: Change in 12 Ounce Cups Per Day of Sugar Sweetened Beverages | -0.7 # of 12 ounce cups per day | Standard Error 0.3 |
p-value: 0.516t-test, 2 sided
Secondary
Child - Screen Time Questionnaire:
total hours of screen time per week as collected by questionnaire given to the parent
Time frame: 12 months
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching and Community Screening | Child - Screen Time Questionnaire: | 27 hours per week | Standard Deviation 12.9 |
| Community Screening | Child - Screen Time Questionnaire: | 29 hours per week | Standard Deviation 12.3 |
p-value: 0.3195% CI: [-7, 23]Mixed Models Analysis