ObesityNCT03086161
Mood and Excess Weight Gain in Adolescent Pregnancy
A study testing Interpersonal Psychotherapy and Treatment-as-usual in people with Obesity and Adolescent Development, run by Colorado State University at 1 site in United States.
Trial summary
50-70% of adolescents gain too much weight during pregnancy, and this excess gain significantly increases their risk of high postpartum weight retention and long-term obesity. In this randomized controlled pilot study, the investigators are evaluating the feasibility and acceptability of a relatively brief… Read more about this study
- Who is it for?
- Ages 3 months to 19 years, women only
- Conditions the study is for
- Obesity, Adolescent Development, Pregnancy Related
- What is being tested?
- Interpersonal Psychotherapy and Treatment-as-usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2015to 17 Jan 2020
- 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 3 months to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 13-19 years of age and the 3-6 month old infants of these adolescent mothers
- Female
- Pregnant, 12-18 weeks gestation
- Patient in the Colorado Adolescent Maternity Program (CAMP) clinic
Who cannot join
- Full-syndrome Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 psychiatric disorder that, in the opinion of the investigators, would impede study compliance and necessitate more intensive treatment (e.g., conduct disorder, schizophrenia, major depressive disorder with active suicidal ideation)
- Major renal, hepatic, endocrinologic (hyperthyroidism or Cushing syndrome), or pulmonary (other than mild asthma) disorder
- Medication affecting mood or body weight
- Major high-risk pregnancy complication (preeclampsia, gestational diabetes, hypertension, multiple gestation, placenta previa, membrane rupture, incompetent cervix)
- Pre-pregnancy BMI <5th percentile for age and sex
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
50-70% of adolescents gain too much weight during pregnancy, and this excess gain significantly increases their risk of high postpartum weight retention and long-term obesity. In this randomized controlled pilot study, the investigators are evaluating the feasibility and acceptability of a relatively brief interpersonal psychotherapy program for reducing excess gestational weight gain during adolescent pregnancy. Compared to treatment-as-usual prenatal care delivered in an adolescent maternity clinic, the investigators will estimate the added benefit of an interpersonal psychotherapy program's effectiveness for reducing excess gestational weight gain, improving maternal postpartum insulin sensitivity, and decreasing maternal and infant adiposity.
Read the detailed description
Obesity and its negative health consequences such as type 2 diabetes and heart disease are major public health concerns. Pregnancy is an ideal opportunity to intervene with young women both to reduce their own likelihood of long-term obesity and to potentially lessen their offspring's obesity risk. Interventions to reduce excessive weight gain during adolescent pregnancy may be particularly important. 50-70% of adolescents gain too much weight during pregnancy, and this excess gain significantly increases their risk of high postpartum weight retention and long-term obesity. Depression and stress-which are common in adolescent pregnancy-also may play a role. Pregnant adolescent females, as well as non-pregnant females, who have more frequent feelings of depression or stress are more likely to gain weight too rapidly or to gain too much weight as they grow. In the current project, the investigators seek to develop a program to prevent excess weight gain that will be feasible to administer in the Colorado Adolescent Maternity Program (CAMP) at Children's Hospital Colorado, University of Colorado Denver, Anschutz Medical Campus, and, that will be acceptable to pregnant teens at-risk for gaining too much weight. After a screening assessment, adolescent females (13-19y) will be randomly assigned to participate in either a 6-session interpersonal psychotherapy (IPT) program + usual care or to CAMP usual care only. The IPT program will involve 6 1-hour meetings with a trained facilitator and focus on improving relationships, mood, stress, and eating in response to negative feelings. The investigators will assess participants midway through the program, immediately after the program, and again at a 3-month postpartum follow-up. The investigators will evaluate to what extent adolescent females attend the program, complete at-home practice assignments, and show changes in mood, stress, relationships, eating, and mindfulness before and after IPT participation compared to usual care only. The investigators also will estimate how program participation relates to weight gain during pregnancy and 3-month postpartum maternal weight retention, adiposity, and insulin sensitivity. The investigators also will study the adiposity of adolescents' 3-month-old infants.
- Conditions
- Obesity, Adolescent Development, Pregnancy Related, Insulin Sensitivity, Interpersonal Relations, Stress
- Being tested
- Interpersonal Psychotherapy, Treatment-as-usual
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal PsychotherapyBehavioural
Six individual 1-hour sessions delivered over the course of pregnancy to address interpersonal problems areas that may lead to emotional eating, physical inactivity, and increased stress during pregnancy, which are drivers of excess weight gain in pregnancy
Treatment-as-usualBehavioural
Routine prenatal care as part of multidisciplinary adolescent pregnancy clinic, including medical (ob/gyn), nutrition, and social work
| Study group | Role | What they receive |
|---|---|---|
| Treatment-as-usual | Active comparator | Treatment-as-usual alone provided in the context of a multi-disciplinary teen pregnancy clinic providing wrap-around medical, nutrition, and social work care. Receives: Behavioral: Treatment-as-usual |
| Interpersonal Psychotherapy | Experimental | Treatment-as-usual plus a six-session interpersonal psychotherapy program delivered as individual sessions by a trained facilitator every 2-3 weeks throughout pregnancy. Receives: Behavioral: Interpersonal Psychotherapy; Behavioral: Treatment-as-usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
Rate of recruitment
Measured: 5-year period
Acceptability
Program session attendance measured as percentage of total sessions (6) attended
Measured: 6-9 months
Acceptability of program
Program acceptability ratings
Measured: 6-9 months
Secondary outcomes (6)
Depressive symptoms
Depressive symptoms measured on the Center for Epidemiologic Studies Depression Scale
Measured: 12 months (9 months of pregnancy plus 3 months postpartum)
Perceived stress
Perceived stress measured on the Perceived Stress Scale
Measured: 12 months (9 months of pregnancy plus 3 months postpartum)
Excess gestational weight gain
Weight gained from first-trimester screening to post-intervention assessment, just prior to delivery
Measured: 9 months
Maternal postpartum insulin sensitivity
Maternal postpartum insulin sensitivity
Measured: 12 months (9 months of pregnancy plus 3 months postpartum)
Maternal postpartum adiposity
Maternal postpartum body fat percentage
Measured: 12 months (9 months of pregnancy plus 3 months postpartum)
Infant adiposity
Infant body fat percentage
Measured: Infants: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start23 Nov 2015
- Primary completion17 Jan 2020
- Study completion17 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, Children's Hospital Colorado
- Responsible party
- Sponsor
- Investigators
- Lauren B Shomaker, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086161
- Sponsor's protocol ID
- 14-1505
- Status last verified
- Feb 2021
- First submitted
- 9 Mar 2017
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shomaker LB, Gulley LD, Clark ELM, Hilkin AM, Pivarunas B, Tanofsky-Kraff M, Nadeau KJ, Barbour LA, Scott SM, Sheeder JL. Protocol for a pilot randomized controlled feasibility study of brief interpersonal psychotherapy for addressing social-emotional needs and preventing excess gestational weight gain in adolescents. Pilot Feasibility Stud. 2020 Mar 20;6:39. doi: 10.1186/s40814-020-00578-1. eCollection 2020.
PubMed 32206334
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mood and Excess Weight Gain in Adolescent Pregnancy
- ClinicalTrials.gov ID
- NCT03086161
- Acronym / sponsor ID
- 14-1505
- Conditions
- Obesity, Adolescent Development, Pregnancy Related, Insulin Sensitivity, Interpersonal Relations, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, Children's Hospital Colorado
- Study start
- 23 Nov 2015 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 22 Mar 2017 (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.
50-70% of adolescents gain too much weight during pregnancy, and this excess gain significantly increases their risk of high postpartum weight retention and long-term obesity. In this randomized controlled pilot study, the investigators are evaluating the feasibility and acceptability of a relatively brief interpersonal psychotherapy program for reducing excess gestational weight gain during adolescent pregnancy. Compared to treatment-as-usual prenatal care delivered in an adolescent maternity clinic, the investigators will estimate the added benefit of an interpersonal psychotherapy program's effectiveness for reducing excess gestational weight gain, improving maternal postpartum insulin sensitivity, and decreasing maternal and infant adiposity.
Detailed description
Obesity and its negative health consequences such as type 2 diabetes and heart disease are major public health concerns. Pregnancy is an ideal opportunity to intervene with young women both to reduce their own likelihood of long-term obesity and to potentially lessen their offspring's obesity risk. Interventions to reduce excessive weight gain during adolescent pregnancy may be particularly important. 50-70% of adolescents gain too much weight during pregnancy, and this excess gain significantly increases their risk of high postpartum weight retention and long-term obesity. Depression and stress-which are common in adolescent pregnancy-also may play a role. Pregnant adolescent females, as well as non-pregnant females, who have more frequent feelings of depression or stress are more likely to gain weight too rapidly or to gain too much weight as they grow. In the current project, the investigators seek to develop a program to prevent excess weight gain that will be feasible to administer in the Colorado Adolescent Maternity Program (CAMP) at Children's Hospital Colorado, University of Colorado Denver, Anschutz Medical Campus, and, that will be acceptable to pregnant teens at-risk for gaining too much weight. After a screening assessment, adolescent females (13-19y) will be randomly assigned to participate in either a 6-session interpersonal psychotherapy (IPT) program + usual care or to CAMP usual care only. The IPT program will involve 6 1-hour meetings with a trained facilitator and focus on improving relationships, mood, stress, and eating in response to negative feelings. The investigators will assess participants midway through the program, immediately after the program, and again at a 3-month postpartum follow-up. The investigators will evaluate to what extent adolescent females attend the program, complete at-home practice assignments, and show changes in mood, stress, relationships, eating, and mindfulness before and after IPT participation compared to usual care only. The investigators also will estimate how program participation relates to weight gain during pregnancy and 3-month postpartum maternal weight retention, adiposity, and insulin sensitivity. The investigators also will study the adiposity of adolescents' 3-month-old infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment-as-usual | Active comparator | Behavioral: Treatment-as-usualTreatment-as-usual alone provided in the context of a multi-disciplinary teen pregnancy clinic providing wrap-around medical, nutrition, and social work care. |
| Interpersonal Psychotherapy | Experimental | Behavioral: Interpersonal Psychotherapy, Behavioral: Treatment-as-usualTreatment-as-usual plus a six-session interpersonal psychotherapy program delivered as individual sessions by a trained facilitator every 2-3 weeks throughout pregnancy. |
Who may qualify
- Ages
- 3 months to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 13-19 years of age and the 3-6 month old infants of these adolescent mothers
- Female
- Pregnant, 12-18 weeks gestation
- Patient in the Colorado Adolescent Maternity Program (CAMP) clinic
Key exclusion criteria (5 listed)
- Full-syndrome Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 psychiatric disorder that, in the opinion of the investigators, would impede study compliance and necessitate more intensive treatment (e.g., conduct disorder, schizophrenia, major depressive disorder with active suicidal ideation)
- Major renal, hepatic, endocrinologic (hyperthyroidism or Cushing syndrome), or pulmonary (other than mild asthma) disorder
- Medication affecting mood or body weight
- Major high-risk pregnancy complication (preeclampsia, gestational diabetes, hypertension, multiple gestation, placenta previa, membrane rupture, incompetent cervix)
- Pre-pregnancy BMI <5th percentile for age and sex
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 |
|---|---|---|
| Interpersonal PsychotherapySix individual 1-hour sessions delivered over the course of pregnancy to address interpersonal problems areas that may lead to emotional eating, physical inactivity, and increased stress during pregnancy, which are drivers of excess weight gain in pregnancy | Behavioural | Interpersonal Psychotherapy |
| Treatment-as-usualRoutine prenatal care as part of multidisciplinary adolescent pregnancy clinic, including medical (ob/gyn), nutrition, and social work | Behavioural | Interpersonal Psychotherapy, Treatment-as-usual |
Primary outcome
Feasibility of recruitment
Time frame: 5-year period
Rate of recruitment
Acceptability
Time frame: 6-9 months
Program session attendance measured as percentage of total sessions (6) attended
Acceptability of program
Time frame: 6-9 months
Program acceptability ratings
6 secondary outcomes
Depressive symptoms
Time frame: 12 months (9 months of pregnancy plus 3 months postpartum)
Perceived stress
Time frame: 12 months (9 months of pregnancy plus 3 months postpartum)
Excess gestational weight gain
Time frame: 9 months
Maternal postpartum insulin sensitivity
Time frame: 12 months (9 months of pregnancy plus 3 months postpartum)
Maternal postpartum adiposity
Time frame: 12 months (9 months of pregnancy plus 3 months postpartum)
Infant adiposity
Time frame: Infants: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Derived from this study: PubMed 32206334Shomaker LB, Gulley LD, Clark ELM, Hilkin AM, Pivarunas B, Tanofsky-Kraff M, Nadeau KJ, Barbour LA, Scott SM, Sheeder JL. Protocol for a pilot randomized controlled feasibility study of brief interpersonal psychotherapy for addressing social-emotional needs and preventing excess gestational weight gain in adolescents. Pilot Feasibility Stud. 2020 Mar 20;6:39. doi: 10.1186/s40814-020-00578-1. eCollection 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.
Lauren B Shomaker, PhD principal investigator
Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal Psychotherapy and Treatment-as-usual in people with Obesity and Adolescent Development, run by Colorado State University at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of recruitment (time frame: 5-year period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03086161, which also lists 1 linked publication.
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 4 Feb 2021.