Pregnancy Related Clinical Trial
Official title:
A Multi-Component Nutrition Program for Pregnant and Parenting Teens, a Pilot Study
NCT number | NCT04265690 |
Other study ID # | H-39461 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2020 |
Est. completion date | March 2021 |
Verified date | October 2020 |
Source | Boston Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 2021 |
Est. primary completion date | March 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 15 Years to 23 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Boston Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in nutrition knowledge | 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 | |
Secondary | Cooking class acceptability | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05017974 -
Research on Improving Sleep During Pregnancy
|
N/A | |
Completed |
NCT03284515 -
Vaccination In Pregnancy Gene Signature: VIP Signature Study
|
||
Recruiting |
NCT05969795 -
Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support
|
Phase 1 | |
Recruiting |
NCT06051201 -
Innovation for Small-scale Experiments: ReceptIVFity Test
|
N/A | |
Recruiting |
NCT04828382 -
Prospective Study of Pregnancy in Women With Cystic Fibrosis
|
||
Enrolling by invitation |
NCT04527926 -
STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy
|
N/A | |
Recruiting |
NCT04278651 -
Early Antenatal Support for Iron Deficiency Anemia
|
Phase 4 | |
Recruiting |
NCT04405700 -
Measuring Adverse Pregnancy and Newborn Congenital Outcomes
|
||
Recruiting |
NCT06258902 -
Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
|
||
Completed |
NCT05487196 -
Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia
|
Phase 2 | |
Completed |
NCT03750968 -
Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects
|
Phase 2 | |
Enrolling by invitation |
NCT06127277 -
Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care
|
N/A | |
Completed |
NCT05897697 -
Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
|
||
Recruiting |
NCT05899101 -
The Impact of Opioid and Cannabis Exposure on Fetal Growth
|
||
Completed |
NCT05502510 -
Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
|
||
Completed |
NCT04296396 -
Opioid Prescription After Cesarean Trial
|
Phase 3 | |
Not yet recruiting |
NCT06069856 -
Multiple Micronutrient Supplementation (MMS) IFA- Iron Dose Acceptability Crossover Trial
|
Phase 3 | |
Not yet recruiting |
NCT06069869 -
Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial
|
Phase 3 | |
Not yet recruiting |
NCT06079918 -
Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania
|
Phase 3 | |
Not yet recruiting |
NCT06163651 -
Evaluating a One-Year Version of the Parent-Child Assistance Program
|
N/A |