Trial Outcomes & Findings for Tools For Teen Moms: Reducing Infant Obesity Risk (NCT NCT02244424)

Last Updated: 2019-03-08

Results Overview

Recumbent infant length (inches) and weight (pounds/ounces) measured at three separate time points. While recumbent infant length was collected in inches and weight collected in pounds/ounces, these measures were converted into z-score measurements for the outcome measurement of change in infant growth. Standardized weight scores are measures of relative weight adjusted for child age and sex. The z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A z-score of 0 is equal to the mean. Negative numbers indicated weight values lower than the mean and the positive numbers indicate weight values higher than the mean.

Recruitment status

COMPLETED

Study phase

Target enrollment

164 participants

Primary outcome timeframe

Baby is less than 2 months; baby is 3 months; baby is 6 months

Results posted on

2019-03-08

Participant Flow

Teen mothers of infants were recruited. Teen mothers participated in the intervention. Infants were included for collection of demographic and weight data. Thus the actual number of participants is doubled to account for both the mothers and infants as participants. Protocol Enrollment number then is 164 ( 82 teen mothers and 82 infants).

Participant milestones

Participant milestones
Measure	Tools for Teen Moms Intervention Group Tools for Teen Moms intervention group (N = 51 teen mothers) will receive daily challenges focusing on: 1) Maternal-Infant Feeding Interaction; and 2) Feeding Practices Challenges. The challenges will cycle through a pre-determined schedule where they are automatically updated each day at midnight. Participants will have a 24-hour period to complete each challenge. The intervention will provide a new daily challenge over six weeks, a time frame selected to provide participants with enough opportunities to form the habit of visiting the website daily. Participants will continue to receive usual MIHP care during the intervention. Tools for Teen Moms: The Tools for Teen Moms intervention is a novel social media intervention platform designed by the investigators which includes cell phone text message reminders, and infant feeding website, and Facebook to increase infant-centered feeding through daily behavioral challenge activities ("challenges") for this population.	MIHP Standard Care MIHP care consists of voluntary home visits: one week postpartum, at six weeks, and six months, and on-going as needed provided by a RN, licensed social worker, RD, infant mental health specialist and/or paraprofessional. Content includes a flexible plan of care with visits based on identified domains for both the mother and the infant. 31 teen mothers received MIHP standard care.
Overall Study STARTED	102	62
Overall Study Infants	51	31
Overall Study Mothers	51	31
Overall Study COMPLETED	82	52
Overall Study NOT COMPLETED	20	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Tools for Teen Moms Intervention Group Tools for Teen Moms intervention group (N = 51 teen mothers) will receive daily challenges focusing on: 1) Maternal-Infant Feeding Interaction; and 2) Feeding Practices Challenges. The challenges will cycle through a pre-determined schedule where they are automatically updated each day at midnight. Participants will have a 24-hour period to complete each challenge. The intervention will provide a new daily challenge over six weeks, a time frame selected to provide participants with enough opportunities to form the habit of visiting the website daily. Participants will continue to receive usual MIHP care during the intervention. Tools for Teen Moms: The Tools for Teen Moms intervention is a novel social media intervention platform designed by the investigators which includes cell phone text message reminders, and infant feeding website, and Facebook to increase infant-centered feeding through daily behavioral challenge activities ("challenges") for this population.	MIHP Standard Care MIHP care consists of voluntary home visits: one week postpartum, at six weeks, and six months, and on-going as needed provided by a RN, licensed social worker, RD, infant mental health specialist and/or paraprofessional. Content includes a flexible plan of care with visits based on identified domains for both the mother and the infant. 31 teen mothers received MIHP standard care.
Overall Study Lost to Follow-up	20	10

Baseline Characteristics

Only mothers were analyzed for this measure.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baby is less than 2 months; baby is 3 months; baby is 6 months

Population: 82 participants were included in analysis at Time 1, 79 at Time 2, and 67 at Time 3. This is due to participants lost to follow-up.

Outcome measures

Outcome measures
Measure	Tools for Teen Moms Intervention Group n=51 Participants Tools for Teen Moms intervention group will receive daily challenges focusing on: 1) Maternal-Infant Feeding Interaction; and 2) Feeding Practices Challenges.	MIHP Standard Care n=31 Participants MIHP care consists of voluntary home visits: one week postpartum, at six weeks, and six months, and on-going as needed provided by a RN, licensed social worker, RD, infant mental health specialist and/or paraprofessional. Content includes a flexible plan of care with visits based on identified domains for both the mother and the infant.
Change in Infant Growth Time 1 (infant 2-8 weeks of age)	-0.46 Weight for age Z-score Standard Deviation 0.90	-0.44 Weight for age Z-score Standard Deviation 0.86
Change in Infant Growth Time 2 (infant about 3 months)	-0.33 Weight for age Z-score Standard Deviation 0.95	-0.46 Weight for age Z-score Standard Deviation 0.93
Change in Infant Growth Time 3 (infant about 6 months)	-0.22 Weight for age Z-score Standard Deviation 1.17	-0.21 Weight for age Z-score Standard Deviation 0.83

Adverse Events

Tools for Teen Moms Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MIHP Standard Care

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. Mildred A. Horodynski

Michigan State University, College of Nursing

Phone: (517) 355-6744

Email: [email protected]; [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Tools for Teen Moms Intervention Group n=102 Participants Tools for Teen Moms intervention group will receive daily challenges focusing on: 1) Maternal-Infant Feeding Interaction; and 2) Feeding Practices Challenges.	MIHP Standard Care n=62 Participants MIHP care consists of voluntary home visits: one week postpartum, at six weeks, and six months, and on-going as needed provided by a RN, licensed social worker, RD, infant mental health specialist and/or paraprofessional. Content includes a flexible plan of care with visits based on identified domains for both the mother and the infant.	Total n=164 Participants Total of all reporting groups
Age, Continuous	17.53 years STANDARD_DEVIATION 1.30 • n=51 Participants • Only mothers were analyzed for this measure.	17.61 years STANDARD_DEVIATION 1.41 • n=31 Participants • Only mothers were analyzed for this measure.	17.56 years STANDARD_DEVIATION 1.33 • n=82 Participants • Only mothers were analyzed for this measure.
Sex: Female, Male Female	51 Participants n=51 Participants • Only mothers were analyzed for this measure.	31 Participants n=31 Participants • Only mothers were analyzed for this measure.	82 Participants n=82 Participants • Only mothers were analyzed for this measure.
Sex: Female, Male Male	0 Participants n=51 Participants • Only mothers were analyzed for this measure.	0 Participants n=31 Participants • Only mothers were analyzed for this measure.	0 Participants n=82 Participants • Only mothers were analyzed for this measure.
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=51 Participants • Only mothers were analyzed for this measure.	14 Participants n=31 Participants • Only mothers were analyzed for this measure.	32 Participants n=82 Participants • Only mothers were analyzed for this measure.
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=51 Participants • Only mothers were analyzed for this measure.	17 Participants n=31 Participants • Only mothers were analyzed for this measure.	50 Participants n=82 Participants • Only mothers were analyzed for this measure.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=51 Participants • Only mothers were analyzed for this measure.	0 Participants n=31 Participants • Only mothers were analyzed for this measure.	0 Participants n=82 Participants • Only mothers were analyzed for this measure.
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=51 Participants • Only mothers were analyzed for this measure.	0 Participants n=31 Participants • Only mothers were analyzed for this measure.	1 Participants n=82 Participants • Only mothers were analyzed for this measure.
Race (NIH/OMB) Asian	2 Participants n=51 Participants • Only mothers were analyzed for this measure.	0 Participants n=31 Participants • Only mothers were analyzed for this measure.	2 Participants n=82 Participants • Only mothers were analyzed for this measure.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=51 Participants • Only mothers were analyzed for this measure.	0 Participants n=31 Participants • Only mothers were analyzed for this measure.	0 Participants n=82 Participants • Only mothers were analyzed for this measure.
Race (NIH/OMB) Black or African American	22 Participants n=51 Participants • Only mothers were analyzed for this measure.	12 Participants n=31 Participants • Only mothers were analyzed for this measure.	34 Participants n=82 Participants • Only mothers were analyzed for this measure.
Race (NIH/OMB) White	24 Participants n=51 Participants • Only mothers were analyzed for this measure.	17 Participants n=31 Participants • Only mothers were analyzed for this measure.	41 Participants n=82 Participants • Only mothers were analyzed for this measure.
Race (NIH/OMB) More than one race	2 Participants n=51 Participants • Only mothers were analyzed for this measure.	2 Participants n=31 Participants • Only mothers were analyzed for this measure.	4 Participants n=82 Participants • Only mothers were analyzed for this measure.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=51 Participants • Only mothers were analyzed for this measure.	0 Participants n=31 Participants • Only mothers were analyzed for this measure.	0 Participants n=82 Participants • Only mothers were analyzed for this measure.
Region of Enrollment United States	51 teen mother participants n=51 Participants • Only mothers were analyzed for this measure.	31 teen mother participants n=31 Participants • Only mothers were analyzed for this measure.	82 teen mother participants n=82 Participants • Only mothers were analyzed for this measure.
Marital Status Married	4 Participants n=51 Participants • Only mothers were analyzed for this measure.	3 Participants n=31 Participants • Only mothers were analyzed for this measure.	7 Participants n=82 Participants • Only mothers were analyzed for this measure.
Marital Status In a Relationship	29 Participants n=51 Participants • Only mothers were analyzed for this measure.	17 Participants n=31 Participants • Only mothers were analyzed for this measure.	46 Participants n=82 Participants • Only mothers were analyzed for this measure.
Marital Status Not in a Relationship	18 Participants n=51 Participants • Only mothers were analyzed for this measure.	11 Participants n=31 Participants • Only mothers were analyzed for this measure.	29 Participants n=82 Participants • Only mothers were analyzed for this measure.
Highest level of education completed 6th grade	0 Participants n=51 Participants • Only mothers were analyzed for this measure.	0 Participants n=31 Participants • Only mothers were analyzed for this measure.	0 Participants n=82 Participants • Only mothers were analyzed for this measure.
Highest level of education completed 7th grade	2 Participants n=51 Participants • Only mothers were analyzed for this measure.	1 Participants n=31 Participants • Only mothers were analyzed for this measure.	3 Participants n=82 Participants • Only mothers were analyzed for this measure.
Highest level of education completed 8th grade	2 Participants n=51 Participants • Only mothers were analyzed for this measure.	2 Participants n=31 Participants • Only mothers were analyzed for this measure.	4 Participants n=82 Participants • Only mothers were analyzed for this measure.
Highest level of education completed 9th grade	2 Participants n=51 Participants • Only mothers were analyzed for this measure.	2 Participants n=31 Participants • Only mothers were analyzed for this measure.	4 Participants n=82 Participants • Only mothers were analyzed for this measure.
Highest level of education completed 10th grade	11 Participants n=51 Participants • Only mothers were analyzed for this measure.	0 Participants n=31 Participants • Only mothers were analyzed for this measure.	11 Participants n=82 Participants • Only mothers were analyzed for this measure.
Highest level of education completed 11th grade	16 Participants n=51 Participants • Only mothers were analyzed for this measure.	13 Participants n=31 Participants • Only mothers were analyzed for this measure.	29 Participants n=82 Participants • Only mothers were analyzed for this measure.
Highest level of education completed 12th grade	6 Participants n=51 Participants • Only mothers were analyzed for this measure.	2 Participants n=31 Participants • Only mothers were analyzed for this measure.	8 Participants n=82 Participants • Only mothers were analyzed for this measure.
Highest level of education completed High school diploma or GED	11 Participants n=51 Participants • Only mothers were analyzed for this measure.	7 Participants n=31 Participants • Only mothers were analyzed for this measure.	18 Participants n=82 Participants • Only mothers were analyzed for this measure.
Highest level of education completed Completed some college credits	1 Participants n=51 Participants • Only mothers were analyzed for this measure.	3 Participants n=31 Participants • Only mothers were analyzed for this measure.	4 Participants n=82 Participants • Only mothers were analyzed for this measure.
Highest level of education completed Missing	0 Participants n=51 Participants • Only mothers were analyzed for this measure.	1 Participants n=31 Participants • Only mothers were analyzed for this measure.	1 Participants n=82 Participants • Only mothers were analyzed for this measure.
Employment Status Full time (at least 35 hours/week)	3 Participants n=51 Participants • Only mothers were analyzed for this measure.	0 Participants n=31 Participants • Only mothers were analyzed for this measure.	3 Participants n=82 Participants • Only mothers were analyzed for this measure.
Employment Status Working part-time	3 Participants n=51 Participants • Only mothers were analyzed for this measure.	4 Participants n=31 Participants • Only mothers were analyzed for this measure.	7 Participants n=82 Participants • Only mothers were analyzed for this measure.
Employment Status Not working	45 Participants n=51 Participants • Only mothers were analyzed for this measure.	27 Participants n=31 Participants • Only mothers were analyzed for this measure.	72 Participants n=82 Participants • Only mothers were analyzed for this measure.
Infant age at enrollment	1.21 months STANDARD_DEVIATION 0.48 • n=51 Participants • Only infants were analyzed for this measure.	1.18 months STANDARD_DEVIATION 0.54 • n=31 Participants • Only infants were analyzed for this measure.	1.20 months STANDARD_DEVIATION 0.50 • n=82 Participants • Only infants were analyzed for this measure.
Infant sex Male	26 Participants n=51 Participants • Only infants were analyzed for this measure.	17 Participants n=31 Participants • Only infants were analyzed for this measure.	43 Participants n=82 Participants • Only infants were analyzed for this measure.
Infant sex Female	25 Participants n=51 Participants • Only infants were analyzed for this measure.	14 Participants n=31 Participants • Only infants were analyzed for this measure.	39 Participants n=82 Participants • Only infants were analyzed for this measure.
Birth weight (kg)	3.21 kg STANDARD_DEVIATION 0.40 • n=51 Participants • Only infants were analyzed for this measure.	3.21 kg STANDARD_DEVIATION 0.43 • n=31 Participants • Only infants were analyzed for this measure.	3.21 kg STANDARD_DEVIATION 0.41 • n=82 Participants • Only infants were analyzed for this measure.
Birth length (cm)	50.98 cm STANDARD_DEVIATION 2.71 • n=51 Participants • Only infants were analyzed for this measure.	50.70 cm STANDARD_DEVIATION 2.88 • n=31 Participants • Only infants were analyzed for this measure.	50.88 cm STANDARD_DEVIATION 2.77 • n=82 Participants • Only infants were analyzed for this measure.
Infant Baseline weight (kg)	4.30 kg STANDARD_DEVIATION 0.75 • n=51 Participants • Only infants were analyzed for this measure.	4.27 kg STANDARD_DEVIATION 0.78 • n=31 Participants • Only infants were analyzed for this measure.	4.29 kg STANDARD_DEVIATION 0.76 • n=82 Participants • Only infants were analyzed for this measure.
Infant Baseline length (cm)	54.75 cm STANDARD_DEVIATION 2.99 • n=51 Participants • Only infants were analyzed for this measure.	55.05 cm STANDARD_DEVIATION 3.61 • n=31 Participants • Only infants were analyzed for this measure.	54.86 cm STANDARD_DEVIATION 3.22 • n=82 Participants • Only infants were analyzed for this measure.
Breastfeeding status at baseline Currently Breastfeeding	18 Participants n=51 Participants • Only mothers were analyzed for this measure.	16 Participants n=31 Participants • Only mothers were analyzed for this measure.	34 Participants n=82 Participants • Only mothers were analyzed for this measure.
Breastfeeding status at baseline Breastfed in the past	15 Participants n=51 Participants • Only mothers were analyzed for this measure.	9 Participants n=31 Participants • Only mothers were analyzed for this measure.	24 Participants n=82 Participants • Only mothers were analyzed for this measure.
Breastfeeding status at baseline Never Breastfed	18 Participants n=51 Participants • Only mothers were analyzed for this measure.	6 Participants n=31 Participants • Only mothers were analyzed for this measure.	24 Participants n=82 Participants • Only mothers were analyzed for this measure.
Solid feeding status at baseline Fed anything other than breastmilk or formula · Yes	0 Participants n=51 Participants • This data pertains only to the infants.	1 Participants n=31 Participants • This data pertains only to the infants.	1 Participants n=82 Participants • This data pertains only to the infants.
Solid feeding status at baseline Fed anything other than breastmilk or formula · No	51 Participants n=51 Participants • This data pertains only to the infants.	30 Participants n=31 Participants • This data pertains only to the infants.	81 Participants n=82 Participants • This data pertains only to the infants.
Solid feeding status at baseline Fed anything other than breastmilk or formula · Missing	0 Participants n=51 Participants • This data pertains only to the infants.	0 Participants n=31 Participants • This data pertains only to the infants.	0 Participants n=82 Participants • This data pertains only to the infants.
Solid feeding status at baseline Given tastes of solid food from mother's finger · Yes	1 Participants n=51 Participants • This data pertains only to the infants.	2 Participants n=31 Participants • This data pertains only to the infants.	3 Participants n=82 Participants • This data pertains only to the infants.
Solid feeding status at baseline Given tastes of solid food from mother's finger · No	49 Participants n=51 Participants • This data pertains only to the infants.	29 Participants n=31 Participants • This data pertains only to the infants.	78 Participants n=82 Participants • This data pertains only to the infants.
Solid feeding status at baseline Given tastes of solid food from mother's finger · Missing	1 Participants n=51 Participants • This data pertains only to the infants.	0 Participants n=31 Participants • This data pertains only to the infants.	1 Participants n=82 Participants • This data pertains only to the infants.