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Mood and Excess Weight Gain in Adolescent Pregnancy

Mood and Excess Weight Gain in Adolescent Pregnancy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03086161
Enrollment
37
Registered
2017-03-22
Start date
2015-11-23
Completion date
2020-01-17
Last updated
2021-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Development, Insulin Sensitivity, Interpersonal Relations, Obesity, Pregnancy Related, Stress

Brief 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 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.

Interventions

BEHAVIORALInterpersonal Psychotherapy

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

BEHAVIORALTreatment-as-usual

Routine prenatal care as part of multidisciplinary adolescent pregnancy clinic, including medical (ob/gyn), nutrition, and social work

Sponsors

University of Colorado, Denver
CollaboratorOTHER
Children's Hospital Colorado
CollaboratorOTHER
Colorado State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)

Masking description

Care providers delivering usual prenatal care are unaware of condition assignment.

Eligibility

Sex/Gender
FEMALE
Age
3 Months to 19 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of recruitment5-year periodRate of recruitment
Acceptability6-9 monthsProgram session attendance measured as percentage of total sessions (6) attended
Acceptability of program6-9 monthsProgram acceptability ratings

Secondary

MeasureTime frameDescription
Maternal postpartum insulin sensitivity12 months (9 months of pregnancy plus 3 months postpartum)Maternal postpartum insulin sensitivity
Depressive symptoms12 months (9 months of pregnancy plus 3 months postpartum)Depressive symptoms measured on the Center for Epidemiologic Studies Depression Scale
Infant adiposityInfants: 3 monthsInfant body fat percentage
Maternal postpartum adiposity12 months (9 months of pregnancy plus 3 months postpartum)Maternal postpartum body fat percentage
Perceived stress12 months (9 months of pregnancy plus 3 months postpartum)Perceived stress measured on the Perceived Stress Scale
Excess gestational weight gain9 monthsWeight gained from first-trimester screening to post-intervention assessment, just prior to delivery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026