Randomized Controlled Trial

. 2016 Oct;50(5):762-774.

doi: 10.1007/s12160-016-9801-0.

A Randomized Controlled Trial to Prevent Depression and Ameliorate Insulin Resistance in Adolescent Girls at Risk for Type 2 Diabetes

Lauren B Shomaker^{1

2

3}, Nichole R Kelly^{4

5

6}, Courtney K Pickworth⁴, Omni L Cassidy^{4

5}, Rachel M Radin^{4

5}, Lisa M Shank^{4

5}, Anna Vannucci^{4

5}, Katherine A Thompson⁴, Sara A Armaiz-Flores⁴, Sheila M Brady⁴, Andrew P Demidowich⁴, Ovidiu A Galescu⁴, Amber B Courville⁷, Cara Olsen⁸, Kong Y Chen⁹, Eric Stice¹⁰, Marian Tanofsky-Kraff^{11

12}, Jack A Yanovski¹³

Affiliations

¹ Section on Growth and Obesity, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Hatfield Clinical Research Center, 10 Center Drive, Building 10, Room 1-3330, MSC 1103, Bethesda, MD, 20892-1103, USA. lauren.shomaker@colostate.edu.
² Department of Medical and Clinical Psychology, Uniformed Services University of the Health Sciences (USUHS), 4301 Jones Bridge Road, Bethesda, MD, 20814-4712, USA. lauren.shomaker@colostate.edu.
³ Department of Human Development and Family Studies and Colorado School of Public Health, Colorado State University, 303A Behavioral Sciences Building, 410 Pitkin Street, Campus Delivery 1570, Fort Collins, CO, 80523-1570, USA. lauren.shomaker@colostate.edu.
⁴ Section on Growth and Obesity, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Hatfield Clinical Research Center, 10 Center Drive, Building 10, Room 1-3330, MSC 1103, Bethesda, MD, 20892-1103, USA.
⁵ Department of Medical and Clinical Psychology, Uniformed Services University of the Health Sciences (USUHS), 4301 Jones Bridge Road, Bethesda, MD, 20814-4712, USA.
⁶ Department of Human Development and Family Studies and Colorado School of Public Health, Colorado State University, 303A Behavioral Sciences Building, 410 Pitkin Street, Campus Delivery 1570, Fort Collins, CO, 80523-1570, USA.
⁷ Nutrition Department, Mark O. Hatfield Clinical Center, NIH, Bethesda, MD, USA.
⁸ Biostatistics, Department of Preventive Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.
⁹ Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes, Digestive and Kidney Diseases, NIH, Bethesda, MD, USA.
¹⁰ Oregon Research Institute, Eugene, OR, USA.
¹¹ Section on Growth and Obesity, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Hatfield Clinical Research Center, 10 Center Drive, Building 10, Room 1-3330, MSC 1103, Bethesda, MD, 20892-1103, USA. marian.tanofsky-kraff@usuhs.edu.
¹² Department of Medical and Clinical Psychology, Uniformed Services University of the Health Sciences (USUHS), 4301 Jones Bridge Road, Bethesda, MD, 20814-4712, USA. marian.tanofsky-kraff@usuhs.edu.
¹³ Section on Growth and Obesity, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Hatfield Clinical Research Center, 10 Center Drive, Building 10, Room 1-3330, MSC 1103, Bethesda, MD, 20892-1103, USA. jy15i@nih.gov.

PMID: 27333897
PMCID: PMC5055426
DOI: 10.1007/s12160-016-9801-0

Randomized Controlled Trial

A Randomized Controlled Trial to Prevent Depression and Ameliorate Insulin Resistance in Adolescent Girls at Risk for Type 2 Diabetes

Lauren B Shomaker et al. Ann Behav Med. 2016 Oct.

. 2016 Oct;50(5):762-774.

doi: 10.1007/s12160-016-9801-0.

Authors

Affiliations

¹ Section on Growth and Obesity, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Hatfield Clinical Research Center, 10 Center Drive, Building 10, Room 1-3330, MSC 1103, Bethesda, MD, 20892-1103, USA. lauren.shomaker@colostate.edu.
² Department of Medical and Clinical Psychology, Uniformed Services University of the Health Sciences (USUHS), 4301 Jones Bridge Road, Bethesda, MD, 20814-4712, USA. lauren.shomaker@colostate.edu.
³ Department of Human Development and Family Studies and Colorado School of Public Health, Colorado State University, 303A Behavioral Sciences Building, 410 Pitkin Street, Campus Delivery 1570, Fort Collins, CO, 80523-1570, USA. lauren.shomaker@colostate.edu.
⁴ Section on Growth and Obesity, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Hatfield Clinical Research Center, 10 Center Drive, Building 10, Room 1-3330, MSC 1103, Bethesda, MD, 20892-1103, USA.
⁵ Department of Medical and Clinical Psychology, Uniformed Services University of the Health Sciences (USUHS), 4301 Jones Bridge Road, Bethesda, MD, 20814-4712, USA.
⁶ Department of Human Development and Family Studies and Colorado School of Public Health, Colorado State University, 303A Behavioral Sciences Building, 410 Pitkin Street, Campus Delivery 1570, Fort Collins, CO, 80523-1570, USA.
⁷ Nutrition Department, Mark O. Hatfield Clinical Center, NIH, Bethesda, MD, USA.
⁸ Biostatistics, Department of Preventive Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.
⁹ Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes, Digestive and Kidney Diseases, NIH, Bethesda, MD, USA.
¹⁰ Oregon Research Institute, Eugene, OR, USA.
¹¹ Section on Growth and Obesity, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Hatfield Clinical Research Center, 10 Center Drive, Building 10, Room 1-3330, MSC 1103, Bethesda, MD, 20892-1103, USA. marian.tanofsky-kraff@usuhs.edu.
¹² Department of Medical and Clinical Psychology, Uniformed Services University of the Health Sciences (USUHS), 4301 Jones Bridge Road, Bethesda, MD, 20814-4712, USA. marian.tanofsky-kraff@usuhs.edu.
¹³ Section on Growth and Obesity, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Hatfield Clinical Research Center, 10 Center Drive, Building 10, Room 1-3330, MSC 1103, Bethesda, MD, 20892-1103, USA. jy15i@nih.gov.

PMID: 27333897
PMCID: PMC5055426
DOI: 10.1007/s12160-016-9801-0

Abstract

Background: Prospective data suggest depressive symptoms worsen insulin resistance and accelerate type 2 diabetes (T2D) onset.

Purpose: We sought to determine whether reducing depressive symptoms in overweight/obese adolescents at risk for T2D would increase insulin sensitivity and mitigate T2D risk.

Method: We conducted a parallel-group, randomized controlled trial comparing a 6-week cognitive-behavioral (CB) depression prevention group with a 6-week health education (HE) control group in 119 overweight/obese adolescent girls with mild-to-moderate depressive symptoms (Center for Epidemiological Studies-Depression Scale [CES-D] ≥16) and T2D family history. Primary outcomes were baseline to post-intervention changes in CES-D and whole body insulin sensitivity index (WBISI), derived from 2-h oral glucose tolerance tests. Outcome changes were compared between groups using ANCOVA, adjusting for respective baseline outcome, puberty, race, facilitator, T2D family history degree, baseline age, adiposity, and adiposity change. Multiple imputation was used for missing data.

Results: Depressive symptoms decreased (p < 0.001) in CB and HE from baseline to posttreatment, but did not differ between groups (ΔCESD = -12 vs. -11, 95 % CI difference = -4 to +1, p = 0.31). Insulin sensitivity was stable (p > 0.29) in CB and HE (ΔWBISI = 0.1 vs. 0.2, 95 % CI difference = -0.6 to +0.4, p = 0.63). Among all participants, reductions in depressive symptoms were associated with improvements in insulin sensitivity (p = 0.02).

Conclusions: Girls at risk for T2D displayed reduced depressive symptoms following 6 weeks of CB or HE. Decreases in depressive symptoms related to improvements in insulin sensitivity. Longer-term follow-up is needed to determine whether either program causes sustained decreases in depressive symptoms and improvements in insulin sensitivity.

Trial registration number: The trial was registered with clinicaltrials.gov (NCT01425905).

Keywords: Adolescence; Depression; Insulin resistance; Randomized controlled trial; Type 2 diabetes.

PubMed Disclaimer

Conflict of interest statement

The authors having nothing to disclose.

Figures

**Figure 2**
Interaction of group by baseline depressive symptoms (CES-D: Center for Epidemiological Studies-Depression Scale) in predicting continuous changes from baseline to post-treatment in depressive symptoms (Panel A; p<0.05), walk/run distance (Panel B; p=0.04), and peak cortisol reactivity (Panel C; p=0.03). Estimates adjusted for baseline depressive symptoms (A), walk/run distance (B), or peak cortisol reactivity (C), and baseline age, puberty, race/ethnicity, baseline percent body fat, change in percent body fat, degree of diabetes family history, and group facilitator.

**Figure 3**
Relationship of change from baseline to post-treatment in depressive symptoms (CES-D: Center for Epidemiological Studies-Depression Scale) and change from baseline to post-treatment in insulin sensitivity (WBISI: Whole Body Insulin Sensitivity Index) by group, accounting for baseline age, puberty, race/ethnicity, baseline percent body fat, change in percent body fat, degree of diabetes family history, and group facilitator (B=−0.04, 95% CI −0.07 to −0.01, p=0.02).

See this image and copyright information in PMC

Cited by

Mindfulness-based group intervention in adolescents at-risk for excess weight gain: A randomized controlled pilot study.
Shomaker LB, Berman Z, Burke M, Annameier SK, Pivarunas B, Sanchez N, Smith AD, Hendrich S, Riggs NR, Legget KT, Cornier MA, Melby C, Johnson SA, Lucas-Thompson R. Shomaker LB, et al. Appetite. 2019 Sep 1;140:213-222. doi: 10.1016/j.appet.2019.05.022. Epub 2019 May 18. Appetite. 2019. PMID: 31112737 Free PMC article. Clinical Trial.
Cognitive-behavioral therapy and exercise training in adolescent females with elevated depression symptoms and at-risk for type 2 diabetes: Protocol for a randomized controlled trial.
Gutierrez-Colina AM, Bristol M, Clark ELM, Sanchez N, Gulley LD, Ruzicka E, Handing EP, Kinsella E, Kutchman E, Witten M, Clementi MA, Thompson T, Pyle L, Aichele S, Goldschmidt AB, Belcher B, Nadeau KJ, Kelsey MM, Shomaker LB. Gutierrez-Colina AM, et al. Contemp Clin Trials. 2023 May;128:107150. doi: 10.1016/j.cct.2023.107150. Epub 2023 Mar 12. Contemp Clin Trials. 2023. PMID: 36918091 Free PMC article.
Indirect Effects of a Cognitive-Behavioral Intervention on Adolescent Weight and Insulin Resistance Through Decreasing Depression in a Randomized Controlled Trial.
Gulley LD, Shomaker LB, Kelly NR, Chen KY, Stice E, Olsen CH, Tanofsky-Kraff M, Yanovski JA. Gulley LD, et al. J Pediatr Psychol. 2019 Nov 1;44(10):1163-1173. doi: 10.1093/jpepsy/jsz064. J Pediatr Psychol. 2019. PMID: 31393981 Free PMC article. Clinical Trial.
Global trends and hotspots of type 2 diabetes in children and adolescents: A bibliometric study and visualization analysis.
Zhang FS, Li HJ, Yu X, Song YP, Ren YF, Qian XZ, Liu JL, Li WX, Huang YR, Gao K. Zhang FS, et al. World J Diabetes. 2025 Jan 15;16(1):96032. doi: 10.4239/wjd.v16.i1.96032. World J Diabetes. 2025. PMID: 39817223 Free PMC article.
Depressive symptoms in adolescent girls at-risk for type 2 diabetes and their parents.
Shomaker LB, Cox S, Lehman DP, Kelly NR, Thompson KA, Mehari RM, Brady SM, Galescu OA, Demidowich AP, Chen KY, Tanofsky-Kraff M, Yanovski JA. Shomaker LB, et al. Psychol Health Med. 2020 Jun;25(5):530-540. doi: 10.1080/13548506.2019.1687914. Epub 2019 Nov 4. Psychol Health Med. 2020. PMID: 31684760 Free PMC article.

See all "Cited by" articles

References

1. Forouhi NG, Wareham NJ. Epidemiology of diabetes. Medicine (Abingdon) 2014;42:698–702. - PMC - PubMed
1. Gregg EW, Zhuo X, Cheng YJ, et al. Trends in lifetime risk and years of life lost due to diabetes in the USA, 1985–2011: a modelling study. Lancet Diabetes Endocrinology. 2014;2:867–874. - PubMed
1. Dabelea D, Mayer-Davis EJ, Saydah S, et al. Prevalence of type 1 and type 2 diabetes among children and adolescents from 2001 to 2009. JAMA. 2014;311:1778–1786. - PMC - PubMed
1. Ducat L, Philipson LH, Anderson BJ. The mental health comorbidities of diabetes. JAMA. 2014;312:691–692. - PMC - PubMed
1. Anderson RJ, Freedland KE, Clouse RE, Lustman PJ. The prevalence of comorbid depression in adults with diabetes: a meta-analysis. Diabetes Care. 2001;24:1069–1078. - PubMed

Publication types

Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Associated data

Actions
- Search in PubMed
- Search in ClinicalTrials.gov

Grants and funding

Z01 HD000641/ImNIH/Intramural NIH HHS/United States

LinkOut - more resources

Full Text Sources
Other Literature Sources
- scite Smart Citations
Medical
- ClinicalTrials.gov
- MedlinePlus Health Information

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

A Randomized Controlled Trial to Prevent Depression and Ameliorate Insulin Resistance in Adolescent Girls at Risk for Type 2 Diabetes

Affiliations

A Randomized Controlled Trial to Prevent Depression and Ameliorate Insulin Resistance in Adolescent Girls at Risk for Type 2 Diabetes

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

Similar articles

Cited by

References

Publication types

MeSH terms

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical

Abstract

Conflict of interest statement

Figures

Similar articles

Cited by

References

Publication types

MeSH terms

Associated data

Related information

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical