Adolescent BehaviorNCT04265690
A Multi-Component Nutrition Program for Pregnant and Parenting Teens
A study testing Cooking classes and Text messages in people with Adolescent Behavior and Pregnancy Related, run by Boston Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 23 years, women only
- Conditions the study is for
- Adolescent Behavior, Pregnancy Related, Postpartum
- What is being tested?
- Cooking classes and Text messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 23 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- None
About this study
Official title: 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).
- Conditions
- Adolescent Behavior, Pregnancy Related, Postpartum
- Being tested
- Cooking classes, Text messages
- Keywords
- Healthy eating behaviors, Eating competence, Centering pregnancy, Centering parenting
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooking classesBehavioural
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.
Text messagesBehavioural
Participants will receive text messages, through a password secured phone, based on their content and frequency preferences.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cooking classes; Behavioral: Text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months
Secondary outcomes (2)
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.
Measured: Baseline, 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study startOct 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Why it stopped: The study never launched due to several COVID-19 related barriers.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marisol De Ornelas, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265690
- Sponsor's protocol ID
- H-39461
- Status last verified
- Oct 2020
- First submitted
- 9 Feb 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Component Nutrition Program for Pregnant and Parenting Teens, a Pilot Study
- ClinicalTrials.gov ID
- NCT04265690
- Acronym / sponsor ID
- H-39461
- Conditions
- Adolescent Behavior, Pregnancy Related, Postpartum
- Keywords
- Healthy eating behaviors, Eating competence, Centering pregnancy, Centering parenting
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study never launched due to several COVID-19 related barriers.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Teen and Tot Centering subjects | Experimental | Behavioral: Cooking classes, Behavioral: Text messagesThe cooking classes and text messages will supplement the subject's standard of care by incorporating text messages and a cooking class. |
Who may qualify
- Ages
- 15 to 23 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cooking classesParticipants 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. | Behavioural | Teen and Tot Centering subjects |
| Text messagesParticipants will receive text messages, through a password secured phone, based on their content and frequency preferences. | Behavioural | Teen and Tot Centering subjects |
Primary outcome
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.
2 secondary outcomes
Change in nutrition knowledge
Time frame: Baseline, 3 months
Cooking class acceptability
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marisol De Ornelas principal investigator
Boston Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Cooking classes and Text messages in people with Adolescent Behavior and Pregnancy Related, run by Boston Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in eating competence (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.