Trial Outcomes & Findings for Family Obesity Intervention: Motivational Interviewing and Community Support (NCT NCT02425046)

NCT ID: NCT02425046

Last Updated: 2024-02-05

Results Overview

Change in Adult BMI from baseline to 12 months

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 472 participants
• Primary outcome timeframe: Outcome was assessed at baseline and 12 months and then calculated by subtracting the baseline value from the value at 12 months
• Results posted on: 2024-02-05

Participant Flow

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.

Participant milestones

Measure	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	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	Lost to Follow up Before Randomization Participants unable to be contacted after baseline and thus never randomized to an intervention group per protocol.
Overall Study STARTED	206	210	56
Overall Study COMPLETED	138	148	0
Overall Study NOT COMPLETED	68	62	56

Reasons for withdrawal

Measure	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	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	Lost to Follow up Before Randomization Participants unable to be contacted after baseline and thus never randomized to an intervention group per protocol.
Overall Study Lost to Follow-up	52	50	56
Overall Study Withdrawal by Subject	16	12	0

Baseline Characteristics

Family Obesity Intervention: Motivational Interviewing and Community Support

Baseline characteristics by cohort

Measure	Health Coaching and Community Screening n=103 Participants 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	Community Screening n=105 Participants 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	Total n=208 Participants Total of all reporting groups
Age, Continuous Adult	35.1 Years STANDARD_DEVIATION 7.1 • n=5 Participants	35.2 Years STANDARD_DEVIATION 7.1 • n=7 Participants	35.1 Years STANDARD_DEVIATION 7.2 • n=5 Participants
Age, Continuous Child	8.4 Years STANDARD_DEVIATION 2.0 • n=5 Participants	8.8 Years STANDARD_DEVIATION 2.0 • n=7 Participants	8.6 Years STANDARD_DEVIATION 1.9 • n=5 Participants
Sex: Female, Male Adult · Female	98 Participants n=5 Participants	100 Participants n=7 Participants	198 Participants n=5 Participants
Sex: Female, Male Adult · Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Child · Female	48 Participants n=5 Participants	52 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Child · Male	55 Participants n=5 Participants	53 Participants n=7 Participants	108 Participants n=5 Participants
Ethnicity (NIH/OMB) Adult · Hispanic or Latino	25 Participants n=5 Participants	31 Participants n=7 Participants	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Adult · Not Hispanic or Latino	77 Participants n=5 Participants	74 Participants n=7 Participants	151 Participants n=5 Participants
Ethnicity (NIH/OMB) Adult · Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Adult · American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Adult · Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Adult · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Adult · Black or African American	32 Participants n=5 Participants	34 Participants n=7 Participants	66 Participants n=5 Participants
Race (NIH/OMB) Adult · White	43 Participants n=5 Participants	42 Participants n=7 Participants	85 Participants n=5 Participants
Race (NIH/OMB) Adult · More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Adult · Unknown or Not Reported	28 Participants n=5 Participants	29 Participants n=7 Participants	57 Participants n=5 Participants
Race (NIH/OMB) Child · American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Child · Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Child · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Child · Black or African American	31 Participants n=5 Participants	34 Participants n=7 Participants	65 Participants n=5 Participants
Race (NIH/OMB) Child · White	47 Participants n=5 Participants	48 Participants n=7 Participants	95 Participants n=5 Participants
Race (NIH/OMB) Child · More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Child · Unknown or Not Reported	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Education Level, Adults High School Not Completed	27 Participants n=5 Participants	26 Participants n=7 Participants	53 Participants n=5 Participants
Education Level, Adults High School Graduate	51 Participants n=5 Participants	51 Participants n=7 Participants	102 Participants n=5 Participants
Education Level, Adults College Graduate	24 Participants n=5 Participants	28 Participants n=7 Participants	52 Participants n=5 Participants
Education Level, Adults Unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Diabetes Status (Adults) Diabetes	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Diabetes Status (Adults) Prediabetes	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Diabetes Status (Adults) Neither	87 Participants n=5 Participants	86 Participants n=7 Participants	173 Participants n=5 Participants
Diabetes Status (Adults) Unknown	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Family Income (before taxes), Adults	29987 dollars STANDARD_DEVIATION 29503 • n=5 Participants	26979 dollars STANDARD_DEVIATION 24818 • n=7 Participants	28437 dollars STANDARD_DEVIATION 26189 • n=5 Participants
BMI, kg/m^2, Adults	39.1 kg/m^2 STANDARD_DEVIATION 7.1 • n=5 Participants	39.7 kg/m^2 STANDARD_DEVIATION 7.2 • n=7 Participants	39.4 kg/m^2 STANDARD_DEVIATION 7.35 • n=5 Participants
BMI z-score (BMIz), Child	1.2 BMI z-score (BMIz) STANDARD_DEVIATION 1.0 • n=5 Participants	1.1 BMI z-score (BMIz) STANDARD_DEVIATION 1.0 • n=7 Participants	1.1 BMI z-score (BMIz) STANDARD_DEVIATION 1.1 • n=5 Participants
Family Nutrition and Physical Activity Scale, Child	60.1 Unit on a scale STANDARD_DEVIATION 8.1 • n=5 Participants	59.6 Unit on a scale STANDARD_DEVIATION 9.2 • n=7 Participants	59.8 Unit on a scale STANDARD_DEVIATION 8.6 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Change in Adult BMI from baseline to 12 months

Outcome measures

Measure	Health Coaching and Community Screening n=103 Participants 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	Community Screening n=105 Participants 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
Change in Adult Body Mass Index	0.3 kg/m2 Standard Error 0.9	-0.1 kg/m2 Standard Error 0.7

PRIMARY outcome

Timeframe: measured at baseline and 12 months - outcome is the change from baseline to 12 months.

Population: All target adults randomized

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.

Outcome measures

Measure	Health Coaching and Community Screening n=103 Participants 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	Community Screening n=105 Participants 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
Change From Baseline in Duration of Daily Moderate to Vigorous Physical Activity	-2.7 minutes per day Standard Error 9.0	0.5 minutes per day Standard Error 5.2

PRIMARY outcome

Timeframe: measured at baseline and 12 months

Population: All target children randomized

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.

Outcome measures

Measure	Health Coaching and Community Screening n=103 Participants 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	Community Screening n=105 Participants 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
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	2.8 units on a scale Standard Error 1.0

PRIMARY outcome

Timeframe: baseline and 12 months

Population: All target children randomized

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.

Outcome measures

Measure	Health Coaching and Community Screening n=103 Participants 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	Community Screening n=105 Participants 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
Target Child - Change in Daily Moderate to Vigorous Physical Activity	-7.0 minutes per day Standard Error 3.0	-9.6 minutes per day Standard Error 3.3

SECONDARY outcome

Timeframe: baseline and 12 months

Population: All randomized target adults

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.

Outcome measures

Measure	Health Coaching and Community Screening n=103 Participants 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	Community Screening n=105 Participants 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
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	-1.3 # of 12 ounce cups per day Standard Error 0.4

SECONDARY outcome

Timeframe: 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.

Reported leisure activity time on the Global Physical Activity Questionnaire reported in minutes per day.

Outcome measures

Measure	Health Coaching and Community Screening n=102 Participants 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	Community Screening n=105 Participants 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
Adult - Physical Activity Questionnaires:	120 minutes per day Standard Deviation 188	100 minutes per day Standard Deviation 193

SECONDARY outcome

Timeframe: 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.

waist circumference in centimeters

Outcome measures

Measure	Health Coaching and Community Screening n=65 Participants 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	Community Screening n=68 Participants 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
Adult - Waist Circumference:	114.3 centimeters Standard Deviation 13.8	119.7 centimeters Standard Deviation 14.9

SECONDARY outcome

Timeframe: 12 months

Population: All target children randomized

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.

Outcome measures

Measure	Health Coaching and Community Screening n=103 Participants 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	Community Screening n=105 Participants 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
Child - BMI Z-score:	0.0 units on a scale Standard Error 0.04	0.0 units on a scale Standard Error 0.0

SECONDARY outcome

Timeframe: 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

total hours of screen time per week as collected by questionnaire given to the parent

Outcome measures

Measure	Health Coaching and Community Screening n=67 Participants 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	Community Screening n=71 Participants 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
Child - Screen Time Questionnaire:	27 hours per week Standard Deviation 12.9	29 hours per week Standard Deviation 12.3

SECONDARY outcome

Timeframe: baseline and 12 months

Population: All targeted children randomized

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.

Outcome measures

Measure	Health Coaching and Community Screening n=103 Participants 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	Community Screening n=105 Participants 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
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	-0.7 # of 12 ounce cups per day Standard Error 0.3

Adverse Events

Health Coaching and Community Screening

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Community Screening

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Helena Laroche

Center for Children's Healthy Lifestyles & Nutrition - Children's Mercy Hospital

Phone: (816) 234-9251

Email: hhlaroche@cmh.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place