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A Multi-Component Nutrition Program for Pregnant and Parenting Teens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04265690
Recruitment Status : Withdrawn (The study never launched due to several COVID-19 related barriers.)
First Posted : February 11, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center

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).

Condition or disease Intervention/treatment Phase
Adolescent Behavior Pregnancy Related Postpartum Behavioral: Cooking classes Behavioral: Text messages Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Multi-Component Nutrition Program for Pregnant and Parenting Teens, a Pilot Study
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

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.
Behavioral: Cooking classes
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.

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT04265690


Sponsors and Collaborators
Boston Medical Center
Investigators
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Principal Investigator: Marisol De Ornelas Boston Medical Center
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Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT04265690    
Other Study ID Numbers: H-39461
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston Medical Center:
Healthy eating behaviors
Eating competence
Centering pregnancy
Centering parenting