A Multi-Component Nutrition Program for Pregnant and Parenting Teens
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|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Recruitment Status : Withdrawn (The study never launched due to several COVID-19 related barriers.)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
|Condition or disease||Intervention/treatment||Phase|
|Adolescent Behavior Pregnancy Related Postpartum||Behavioral: Cooking classes Behavioral: Text messages||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|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)|
|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|
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.
- 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.
- 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.
- 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.
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
|Principal Investigator:||Marisol De Ornelas||Boston Medical Center|