Clinical trial NCT04265690: A Multi-Component Nutrition Program for Pregnant and Parenting Teens
Official title: A Multi-Component Nutrition Program for Pregnant and Parenting Teens, a Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Adolescent Behavior
Pregnancy Related
Postpartum
Keywords: Healthy eating behaviors
Eating competence
Centering pregnancy
Centering parenting
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: For this proof of concept/pilot trial, we will assess the feasibility and impact of this multi-component nutrition program on improving healthy eating behaviors and eating competence. However, because we are proposing a proof of concept pilot and feasibility study, in our experience and that of others, our proposed sample size generally provides sufficient data to estimate subject retention, distribution of variables and feasibility as we plan for a larger-multi-site RCT of the proposed study. We expect our intervention to demonstrate the feasibility of the intervention in a clinic setting.
Primary purpose: PREVENTION

Brief summary: Improving nutrition during pregnancy is critical for maternal and child health, but even more so among pregnant adolescents. Several studies have shown that poor nutrition and diet quality during pregnancy is related to adverse health outcomes among both the mother and the infant. During pregnancy, the fetus's nutrition and diet quality is largely dependent on the mother. A teenage mother is in a vulnerable position because she needs to meet the demands of her own growth and development in addition to the growth and development of her baby, which can be extremely challenging, especially for mothers who are from disadvantaged communities. Surprisingly, given their unique needs, there is limited literature on multicomponent behavioral interventions that adequately address the unique nutritional needs of pregnant adolescent women and their fetuses, which is why interventions targeted at promoting healthy behaviors among low-income, racially diverse pregnant teens should be a public health priority, particularly in the U.S. This study aims to assess whether a multicomponent behavioral intervention improves intention, initiation, and sustained healthy eating behaviors and eating competence among Pregnant adolescents (second trimester) and Postpartum adolescent mothers (\<6 months).


Eligibility criteria: Inclusion Criteria:

* 15-23 years of age
* be at least 3 months pregnant; or
* have a baby less than 2 years old
* be participating in Teen and Tot Centering group-care visits

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in eating competence
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Change in nutrition knowledge
timeFrame: Baseline, 3 months
measure: Cooking class acceptability
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Boston Medical Center
name: Marisol De Ornelas
role: PRINCIPAL_INVESTIGATOR
References: