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Completed

NCT Number: NCT03086161

Mood and Excess Weight Gain in Adolescent Pregnancy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interpersonal psychotherapy

Behavioral

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-usual

Behavioral

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

Primary outcomes

  1. Feasibility of recruitment

    Time frame: 5-year period

    Rate of recruitment

  2. Acceptability

    Time frame: 6-9 months

    Program session attendance measured as percentage of total sessions (6) attended

  3. Acceptability of program

    Time frame: 6-9 months

    Program acceptability ratings

Secondary outcomes

  1. Depressive symptoms

    Time frame: 12 months (9 months of pregnancy plus 3 months postpartum)

    Depressive symptoms measured on the Center for Epidemiologic Studies Depression Scale

  2. Perceived stress

    Time frame: 12 months (9 months of pregnancy plus 3 months postpartum)

    Perceived stress measured on the Perceived Stress Scale

  3. Excess gestational weight gain

    Time frame: 9 months

    Weight gained from first-trimester screening to post-intervention assessment, just prior to delivery

  4. Maternal postpartum insulin sensitivity

    Time frame: 12 months (9 months of pregnancy plus 3 months postpartum)

    Maternal postpartum insulin sensitivity

  5. Maternal postpartum adiposity

    Time frame: 12 months (9 months of pregnancy plus 3 months postpartum)

    Maternal postpartum body fat percentage

  6. Infant adiposity

    Time frame: Infants: 3 months

    Infant body fat percentage

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Collaborators

  • Children's Hospital Colorado
  • University of Colorado, Denver

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Mar 22, 2017
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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