Mothers and Others: Family-based Obesity Prevention for Infants and Toddlers
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ClinicalTrials.gov Identifier: NCT01938118 |
Recruitment Status :
Completed
First Posted : September 10, 2013
Last Update Posted : April 19, 2018
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Condition or disease | Intervention/treatment | Phase |
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Obesity | Behavioral: Obesity Prevention Group Behavioral: Injury Prevention Group | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 430 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Prevention |
Official Title: | Mothers and Others: Family-based Obesity Prevention for Infants and Toddlers |
Actual Study Start Date : | October 2013 |
Actual Primary Completion Date : | December 2017 |
Actual Study Completion Date : | December 2017 |

Arm | Intervention/treatment |
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Experimental: Obesity Prevention Group
Mothers and families receive a developmentally appropriate educational intervention designed to promote healthy lifestyle behaviors for prevention of excessive weight gain between birth to 15 months of life. Educational content is delivered through eight home visits, five newsletters and twice weekly text messages. At several time points the mother identifies another family member/caregiver to actively participate in the program with her.
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Behavioral: Obesity Prevention Group |
Active Comparator: Injury Prevention Group
Mothers and families receive a developmentally appropriate educational intervention designed to promote automobile and home safety behaviors for prevention of childhood injury. Educational content is delivered through eight home visits, five newsletters and twice weekly text messages. At several time points the mother identifies another family member/caregiver, who is only asked to complete surveys/assessments.
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Behavioral: Injury Prevention Group |
- Mean weight-for-length z-score at 15 months of age [ Time Frame: 15 months of age ]Anthropometrics measured directly in the home by trained study staff
- Proportion of infants ever breastfed and exclusively breastfed at 3 and 6 months of age [ Time Frame: 3 and 6 months of age ]Measured using an Infant Diet History questionnaire adapted after the Infant Feeding Practices Study II
- Proportion of infants fed complementary foods before 4 or 6 months of age [ Time Frame: 4 and 6 months of age ]Measured using an Infant Diet History questionnaire adapted after the Infant Feeding Practices Study II
- Infant dietary intake of fruits and vegetables, whole grains, desserts and sweets, and salty snacks at 3, 6, 9, 12 and 18 months of age [ Time Frame: 3, 6, 9, 12 and 15 months of age ]Measured at 3, 6, 9 and 12 months using an Infant Diet History questionnaire adapted after the Infant Feeding Practices Study II. Measured at 15 months using the Nutrition Data System for Research (NDSR)
- Duration of infant sleep (hours of total daily sleep, hours of nocturnal sleep, and number of night awakenings) at 3, 6, 9, 12 and 18 months of age [ Time Frame: 3, 6, 9, 12 and 15 months of age ]Measured using the Brief Infant Sleep Questionnaire (BISQ)
- Infant exposure to television and electronic media (number of hours of screen time per day, proportion of infants with a T.V. or other media screen in bedroom) at 3, 6, 9, 12 and 18 months of age [ Time Frame: 3, 6, 9, 12 and 15 months of age ]
- Breastfeeding attitude score at 28 and 37 weeks gestation and at 1, 3, 6, 9 and 12 months of age [ Time Frame: 28 and 37 weeks gestation and 1, 3, 6, 9 and 12 months of age ]Measured using the Iowa Infant Feeding Attitude Scale
- Breastfeeding self-efficacy score at 1, 3, 6, 9 and 12 months [ Time Frame: 1, 3, 6, 9 and 12 months of age ]Measured using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)
- Social support from family score at 1, 3, 6, 9 and 12 months of age [ Time Frame: 1, 3, 6, 9 and 12 months of age ]Measured using the Perceived Social Support from Family Scale
- Responsive feeding style score at 28 and 37 weeks gestation and 1, 3, 6, 9, 12 and 15 months of age [ Time Frame: 28 and 37 weeks gestation and at 1, 3, 6, 9, 12 and 15 months of age ]Measured using the Infant Feeding Styles Questionnaire (IFSQ) (belief items only at 28 and 37 weeks gestation, full scale at all other time points) and the Responsiveness to Child Feeding Cues Scale (RCFCS)at 3, 9 and 15 months.
- Perception of infant fussiness (i.e. IBQ-R 'Distress to Limitations' score and 'Activity' score) at 3, 6, 9 and 12 months of age [ Time Frame: 3, 6, 9 and 12 months of age ]Measured using the Infant Behavior Questionnaire-Revised (IBQ-R)
- Change in weight-for-length z-score between birth to 15 months [ Time Frame: Birth to 15 months ]Anthropometrics measured directly in the home by trained study staff
- Proportion of infants that are overweight, defined as weight-for-length z-score ≥ 95th percentile, at 15 months [ Time Frame: 15 months of age ]Anthropometrics measured directly in the home by trained study staff

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Self identifies as non-Hispanic, African-American
- Less than 28 weeks pregnant at time of screening and recruitment
- Expecting a singleton birth
- Maternal age at time of birth will be at 18-39 years
- Lives within specified distance of study site
- Not intending to leave study area before expectant child's 15th month of life
- Agreeable to referring another family member/caregiver to participate in the study
Exclusion Criteria:
- Pre-term birth (<= 36 weeks gestation)
- Less than 18 years at time of delivery
- Delivers infant with a congenital anomaly or medical condition that significantly affects feeding (e.g., cleft lip and/or palate, metabolic disease)
- Delivers multiples
- Newborn nursery, neonatal intensive care unit (NICU), or maternity floor stay for 7 or more days after the delivery

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938118
United States, North Carolina | |
Center for Women's Health Research, University of North Carolina | |
Chapel Hill, North Carolina, United States, 27599 |
Principal Investigator: | Margaret E Bentley, PhD | University of North Carolina, Chapel Hill | |
Study Director: | Heather Wasser, PhD | University of North Carolina, Chapel Hill |
Responsible Party: | University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT01938118 |
Other Study ID Numbers: |
12-0510 1R01HD073237-01 ( U.S. NIH Grant/Contract ) |
First Posted: | September 10, 2013 Key Record Dates |
Last Update Posted: | April 19, 2018 |
Last Verified: | April 2018 |
Infant diet Family diet Responsive feeding |
Infant temperament Physical activity Television |
Obesity Overnutrition Nutrition Disorders Overweight Body Weight |