- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04265690
A Multi-Component Nutrition Program for Pregnant and Parenting Teens
October 4, 2020 updated by: Boston Medical Center
A Multi-Component Nutrition Program for Pregnant and Parenting Teens, a Pilot Study
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).
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 23 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Teen and Tot Centering subjects
The cooking classes and text messages will supplement the subject's standard of care by incorporating text messages and a cooking class.
|
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.
Participants will receive text messages, through a password secured phone, based on their content and frequency preferences.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in eating competence
Time Frame: Baseline, 3 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in nutrition knowledge
Time Frame: Baseline, 3 months
|
Assess nutrition knowledge based on the General Nutrition Knowledge Questionnaire (GNKQ).
The scale assesses: dietary recommendations, food groups, healthy food choices, and diet, disease, and weight associations.
The GNKQ questionnaire is 88 items.
The highest total GNKQ score is 88 and the lowest is 0. Higher GNKQ scores are correlated with better nutrition knowledge.
|
Baseline, 3 months
|
Cooking class acceptability
Time Frame: 3 months
|
The acceptability of the cooking classes will be assessed by a short survey with 4 questions and a 5-point likert scale that was made by the investigator.
The survey will ask about their opinions about the cooking classes' nutrition information delivery.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marisol De Ornelas, Boston Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
October 1, 2020
Primary Completion (ANTICIPATED)
March 1, 2021
Study Completion (ANTICIPATED)
March 1, 2021
Study Registration Dates
First Submitted
February 9, 2020
First Submitted That Met QC Criteria
February 9, 2020
First Posted (ACTUAL)
February 11, 2020
Study Record Updates
Last Update Posted (ACTUAL)
October 8, 2020
Last Update Submitted That Met QC Criteria
October 4, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- H-39461
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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