A Multi-Component Nutrition Program for Pregnant and Parenting Teens

NCT04265690 | Withdrawn

• 1 other identifier: H-39461
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Adolescent Behavior; Pregnancy Related; Postpartum

Keywords

Healthy eating behaviors; Eating competence; Centering pregnancy; Centering parenting

Outcome Measures

Primary Outcomes (1)

• Change in eating competence

  Eating competence will be measured using the ecSatter Inventory (EcSI 2.0) which assesses: eating attitudes, food acceptance, food regulation, and contextual skills. The 16 item EcSI 2.0 questionnaire uses a 5-point likert scale with scores from 3 to 0 \[Always=3; Often =2; Sometimes=1, Rarely=0; Never=0\]. Total EcSI 2.0 scores range from 0 to 48. Higher EcSI 2.0 scores are correlated with better eating competence. Eating competence cutoff is 32 and above.

  Baseline, 3 months

Secondary Outcomes (2)

• Change in nutrition knowledge

  Baseline, 3 months

• Cooking class acceptability

  3 months

Study Arms (1)

Teen and Tot Centering subjects

EXPERIMENTAL

The cooking classes and text messages will supplement the subject's standard of care by incorporating text messages and a cooking class.

Behavioral: Cooking classes; Behavioral: Text messages

Interventions

Cooking classes BEHAVIORAL

Participants will receive 2 cooking classes (each 1-hour long) during their Centering group-care visit at the BMC teaching kitchen, taught by a Registered Dietitian. The recipes taught during the cooking classes will follow the Special Supplemental Nutrition Program for Women, Infants, and Children, the 2015-2020 Dietary Guidelines for Americans, and recommendations from The American College of Obstetricians and Gynecologists.

Teen and Tot Centering subjects

Text messages BEHAVIORAL

Participants will receive text messages, through a password secured phone, based on their content and frequency preferences.

Teen and Tot Centering subjects

Eligibility Criteria

• Age: 15 Years - 23 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Boston Medical Center: lead

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Marisol De Ornelas

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 9, 2020
• First Posted: February 11, 2020
• Study Start: October 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share