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Improving the Eating Habits of Mother and Her Infant Via Sugar Reduction (MAMITA)

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University of Southern California

Status

Active, not recruiting

Conditions

Obesity

Treatments

Other: Home water delivery
Behavioral: Control health education program
Behavioral: Sugar reduction health education program

Study type

Interventional

Funder types

Other

Identifiers

NCT03141346
CHLA-18-00571

Details and patient eligibility

About

The purpose of this study is to determine whether a health education program incorporating sugar sweetened beverage and juice (SSB/J) reduction and home water delivery affects maternal and infant risk for obesity by randomizing mother-infant dyads to one of three 24-month interventions: Group 1 (control): standard health education program only; Group 2 (translation): health education program focused on sugar reduction; and Group 3 (efficacy): health education program focused on sugar reduction and bottled water delivery. The intervention program will be delivered by trained health educators during in-person home visits, or virtually via phone or video calls.

Full description

This study will determine whether a health education program incorporating sugar sweetened beverage and juice (SSB/J) reduction and home water delivery affects maternal and infant risk for obesity. The postpartum period is a time of both opportunity and vulnerability for mothers and their infants to diminish risk for obesity and related health problems. This is particularly relevant in the context of Hispanic families. Hispanic mothers are at high-risk for excess gestational weight gain and postpartum weight retention, and their infants are at high-risk for rapid weight gain associated with early onset obesity. A contributing factor may be their intake of SSB/J. There is a high prevalence of reported SSB/J consumption in low-income Hispanic households, and Hispanic mothers are more likely to incorporate sweet foods during weaning. Because evidence suggests that obese Hispanic children are responsive to SSB/J reduction and substitution with non-caloric beverages, this may be a potential strategy for Hispanic mothers that may also be beneficial for their infants.

This study will be conducted in Los Angeles. Two-hundred-and-forty Hispanic mothers and their infants will be recruited. They will be randomly assigned to: group 1, a standard health education program only; group 2, a health education program that incorporates sugar reduction; and group 3, a health education program that incorporates sugar reduction with home bottled water delivery. The intervention program will be delivered by trained health educators during in-person home visits, or virtually via phone or video calls. The main outcomes are maternal weight status and infant weight change. We will also assess maternal and infant diet using 24-hour recalls, and maternal feeding style and infant eating behaviors using questionnaires.

Enrollment

211 patients

Sex

Female

Ages

18 to 59 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Mothers who self-identify as Hispanic
  • Mothers who have or have had singleton births
  • Mothers will be recruited prior to their infant's birth or up to 1-month postpartum
  • Mothers must be able/willing to understand the procedures of the study, and must be able to read English or Spanish at a 5th grade level
  • Mothers who are habitual consumers of sugar sweetened beverages and juices

Exclusion criteria

  • Physician diagnosis of a major medical illness (including type 1 or type 2 diabetes) or eating disorder in mothers
  • Physical, mental, or cognitive issues that prevent participation
  • Chronic use of any medication that may affect body weight or composition, insulin resistance, or lipid profiles
  • Current smoking (more than 1 cigarette in the past week) or use of other recreational drugs
  • Clinical diagnosis of gestational diabetes
  • Pre-term/low birth weight infants, or diagnosis of any fetal abnormalities
  • Mothers less than 18 years of age at the time of delivery will not be eligible as to avoid potential confounding from those subjects who might still be completing adolescent growth

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

211 participants in 3 patient groups

Control
Active Comparator group
Description:
A control health education program to promote general health and safety
Treatment:
Behavioral: Control health education program
Sugar Reduction Program Only
Experimental group
Description:
A health education program that focuses on sugar reduction
Treatment:
Behavioral: Sugar reduction health education program
Sugar Reduction Program & Water Delivery
Experimental group
Description:
A health education program that focuses on sugar reduction and provides home bottled water delivery
Treatment:
Behavioral: Sugar reduction health education program
Other: Home water delivery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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