NCT02745795

Brief Summary

The objective of the study is to investigate the efficacy of motivational interview intervention with adolescent students at a school environment on the adhesion to a therapeutic plan to loose weight.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
83

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable obesity

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

7 months

First QC Date

April 5, 2016

Last Update Submit

April 17, 2016

Conditions

Keywords

Motivational interviewadolescentsobesityoverweightphysical activitydiet

Outcome Measures

Primary Outcomes (1)

  • Motivation scores to adhere to a diet and physical activity plan

    Motivation scores assessed by two self-report confidential paper questionnaires (Self-regulation and perceived competence questionnaire to begin or maintain an healthy diet and Self-regulation and perceived competence questionnaire to begin or maintain regular physical exercise)

    Six months

Secondary Outcomes (8)

  • Self-concept score

    Six months

  • Quality of life score

    Six months

  • Depressive symptoms score

    Six months

  • Anxiety symptoms

    Six months

  • Abdominal circumference in centimeters

    Six months

  • +3 more secondary outcomes

Study Arms (2)

MIG: Motivational Interview Group

EXPERIMENTAL

Group submitted to three face-to-face interviews using motivational interview techniques to elicit motivation for adhesion to a diet and physical activity plan intended to loose weight. The interviews will be done at schools with three months intervals.

Behavioral: Motivational Interview

CIG: Conventional Intervention Group

SHAM COMPARATOR

Group submitted to three face-to-face interviews without using motivational interview techniques to elicit motivation for adhesion to a diet and physical activity plan intended to loose weight. The interviews will be done at schools with three months intervals.

Behavioral: Conventional Interview

Interventions

Three face-to-face interviews using motivational interview techniques to elicit motivation for adhesion to a diet and physical activity plan intended to loose weight. The interviews will be done at schools with three months intervals.

MIG: Motivational Interview Group

Three face-to-face interviews without using motivational interview techniques to elicit motivation for adhesion to a diet and physical activity plan intended to loose weight. The interviews will be done at schools with three months intervals.

CIG: Conventional Intervention Group

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age between 14 and 19 years old
  • Body mass index percentile equal or above 85th percentile according to World Health Organization charts (de Onis 2010)

You may not qualify if:

  • recent weight loss of 10% or more of body weight
  • pregnancy
  • breastfeeding
  • endocrine disease
  • present therapy with antidepressant or hypoglycemic drugs
  • present treatment for food behavior disease or depression
  • cognitive impairment of the student or his/her legal tutor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (30)

  • Physical Activity Guidelines Advisory Committee report, 2008. To the Secretary of Health and Human Services. Part A: executive summary. Nutr Rev. 2009 Feb;67(2):114-20. doi: 10.1111/j.1753-4887.2008.00136.x. No abstract available.

    PMID: 19178654BACKGROUND
  • Hettema J, Steele J, Miller WR. Motivational interviewing. Annu Rev Clin Psychol. 2005;1:91-111. doi: 10.1146/annurev.clinpsy.1.102803.143833.

    PMID: 17716083BACKGROUND
  • Bean MK, Mazzeo SE, Stern M, Bowen D, Ingersoll K. A values-based Motivational Interviewing (MI) intervention for pediatric obesity: study design and methods for MI Values. Contemp Clin Trials. 2011 Sep;32(5):667-74. doi: 10.1016/j.cct.2011.04.010. Epub 2011 Apr 29.

    PMID: 21554994BACKGROUND
  • Tanofsky-Kraff M, Shomaker LB, Wilfley DE, Young JF, Sbrocco T, Stephens M, Ranzenhofer LM, Elliott C, Brady S, Radin RM, Vannucci A, Bryant EJ, Osborn R, Berger SS, Olsen C, Kozlosky M, Reynolds JC, Yanovski JA. Targeted prevention of excess weight gain and eating disorders in high-risk adolescent girls: a randomized controlled trial. Am J Clin Nutr. 2014 Oct;100(4):1010-8. doi: 10.3945/ajcn.114.092536. Epub 2014 Aug 13.

    PMID: 25240070BACKGROUND
  • de Onis M, Lobstein T. Defining obesity risk status in the general childhood population: which cut-offs should we use? Int J Pediatr Obes. 2010 Dec;5(6):458-60. doi: 10.3109/17477161003615583. Epub 2010 Mar 17. No abstract available.

    PMID: 20233144BACKGROUND
  • Aviram A, Westra HA. The impact of motivational interviewing on resistance in cognitive behavioural therapy for generalized anxiety disorder. Psychother Res. 2011 Nov;21(6):698-708. doi: 10.1080/10503307.2011.610832. Epub 2011 Aug 31.

    PMID: 21878034BACKGROUND
  • Kosti RI, Panagiotakos DB. The epidemic of obesity in children and adolescents in the world. Cent Eur J Public Health. 2006 Dec;14(4):151-9. doi: 10.21101/cejph.a3398.

    PMID: 17243492BACKGROUND
  • Resnicow K, Jackson A, Wang T, De AK, McCarty F, Dudley WN, Baranowski T. A motivational interviewing intervention to increase fruit and vegetable intake through Black churches: results of the Eat for Life trial. Am J Public Health. 2001 Oct;91(10):1686-93. doi: 10.2105/ajph.91.10.1686.

    PMID: 11574336BACKGROUND
  • Faria L. Harter's self-perception profile for children adapted for use with young Portuguese students. Percept Mot Skills. 2001 Jun;92(3 Pt 1):711-20. doi: 10.2466/pms.2001.92.3.711.

    PMID: 11453198BACKGROUND
  • Gee S, Chin D, Ackerson L, Woo D, Howell A. Prevalence of childhood and adolescent overweight and obesity from 2003 to 2010 in an integrated health care delivery system. J Obes. 2013;2013:417907. doi: 10.1155/2013/417907. Epub 2013 Jul 18.

    PMID: 23970960BACKGROUND
  • Kovacs M. The Children's Depression, Inventory (CDI). Psychopharmacol Bull. 1985;21(4):995-8. No abstract available.

    PMID: 4089116BACKGROUND
  • Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.

    PMID: 11468499BACKGROUND
  • Gidding SS, Dennison BA, Birch LL, Daniels SR, Gillman MW, Lichtenstein AH, Rattay KT, Steinberger J, Stettler N, Van Horn L; American Heart Association; American Academy of Pediatrics. Dietary recommendations for children and adolescents: a guide for practitioners: consensus statement from the American Heart Association. Circulation. 2005 Sep 27;112(13):2061-75. doi: 10.1161/CIRCULATIONAHA.105.169251.

    PMID: 16186441BACKGROUND
  • Neumark-Sztainer DR, Friend SE, Flattum CF, Hannan PJ, Story MT, Bauer KW, Feldman SB, Petrich CA. New moves-preventing weight-related problems in adolescent girls a group-randomized study. Am J Prev Med. 2010 Nov;39(5):421-32. doi: 10.1016/j.amepre.2010.07.017.

    PMID: 20965379BACKGROUND
  • Flattum C, Friend S, Story M, Neumark-Sztainer D. Evaluation of an individualized counseling approach as part of a multicomponent school-based program to prevent weight-related problems among adolescent girls. J Am Diet Assoc. 2011 Aug;111(8):1218-23. doi: 10.1016/j.jada.2011.05.008.

    PMID: 21802570BACKGROUND
  • Feinson J, Atkinson A, Hassink S. How a primary care quality improvement initiative is implementing the expert recommendations on childhood obesity. Del Med J. 2010 Feb;82(2):57-65.

    PMID: 20369454BACKGROUND
  • Lang PJ, Bradley MM. Emotion and the motivational brain. Biol Psychol. 2010 Jul;84(3):437-50. doi: 10.1016/j.biopsycho.2009.10.007. Epub 2009 Oct 30.

    PMID: 19879918BACKGROUND
  • Wang Y, Lobstein T. Worldwide trends in childhood overweight and obesity. Int J Pediatr Obes. 2006;1(1):11-25. doi: 10.1080/17477160600586747.

    PMID: 17902211BACKGROUND
  • Resnicow K, Davis R, Rollnick S. Motivational interviewing for pediatric obesity: Conceptual issues and evidence review. J Am Diet Assoc. 2006 Dec;106(12):2024-33. doi: 10.1016/j.jada.2006.09.015.

    PMID: 17126634BACKGROUND
  • Neumark-Sztainer D, Story M, Hannan PJ, Rex J. New Moves: a school-based obesity prevention program for adolescent girls. Prev Med. 2003 Jul;37(1):41-51. doi: 10.1016/s0091-7435(03)00057-4.

    PMID: 12799128BACKGROUND
  • Ryan RM, Deci EL. Intrinsic and Extrinsic Motivations: Classic Definitions and New Directions. Contemp Educ Psychol. 2000 Jan;25(1):54-67. doi: 10.1006/ceps.1999.1020.

    PMID: 10620381BACKGROUND
  • Ball GD, Mackenzie-Rife KA, Newton MS, Alloway CA, Slack JM, Plotnikoff RC, Goran MI. One-on-one lifestyle coaching for managing adolescent obesity: Findings from a pilot, randomized controlled trial in a real-world, clinical setting. Paediatr Child Health. 2011 Jun;16(6):345-50. doi: 10.1093/pch/16.6.345.

    PMID: 22654546BACKGROUND
  • Flattum C, Friend S, Neumark-Sztainer D, Story M. Motivational interviewing as a component of a school-based obesity prevention program for adolescent girls. J Am Diet Assoc. 2009 Jan;109(1):91-4. doi: 10.1016/j.jada.2008.10.003.

    PMID: 19103327BACKGROUND
  • Burke BL, Arkowitz H, Menchola M. The efficacy of motivational interviewing: a meta-analysis of controlled clinical trials. J Consult Clin Psychol. 2003 Oct;71(5):843-61. doi: 10.1037/0022-006X.71.5.843.

    PMID: 14516234BACKGROUND
  • Council on Sports Medicine and Fitness; Council on School Health. Active healthy living: prevention of childhood obesity through increased physical activity. Pediatrics. 2006 May;117(5):1834-42. doi: 10.1542/peds.2006-0472.

    PMID: 16651347BACKGROUND
  • Moyers TB, Martin T, Manuel JK, Hendrickson SM, Miller WR. Assessing competence in the use of motivational interviewing. J Subst Abuse Treat. 2005 Jan;28(1):19-26. doi: 10.1016/j.jsat.2004.11.001.

    PMID: 15723728BACKGROUND
  • Lurbe E, Cifkova R, Cruickshank JK, Dillon MJ, Ferreira I, Invitti C, Kuznetsova T, Laurent S, Mancia G, Morales-Olivas F, Rascher W, Redon J, Schaefer F, Seeman T, Stergiou G, Wuhl E, Zanchetti A; European Society of Hypertension. Management of high blood pressure in children and adolescents: recommendations of the European Society of Hypertension. J Hypertens. 2009 Sep;27(9):1719-42. doi: 10.1097/HJH.0b013e32832f4f6b.

    PMID: 19625970BACKGROUND
  • Irby M, Kaplan S, Garner-Edwards D, Kolbash S, Skelton JA. Motivational interviewing in a family-based pediatric obesity program: a case study. Fam Syst Health. 2010 Sep;28(3):236-46. doi: 10.1037/a0020101.

    PMID: 20939628BACKGROUND
  • National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents. The fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and adolescents. Pediatrics. 2004 Aug;114(2 Suppl 4th Report):555-76. No abstract available.

    PMID: 15286277BACKGROUND
  • Freira S, Lemos MS, Fonseca H, Williams G, Ribeiro M, Pena F, do Ceu Machado M. Anthropometric outcomes of a motivational interviewing school-based randomized trial involving adolescents with overweight. Eur J Pediatr. 2018 Jul;177(7):1121-1130. doi: 10.1007/s00431-018-3158-2. Epub 2018 May 15.

MeSH Terms

Conditions

ObesityOverweightMotor Activity

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Marina Serra-de-Lemos, PhD

    Faculty of Psychology and Education Sciences of University of Porto

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Department of Pediatry of Centro Hospitalar Lisboa Norte, Chair of Pediatry at Medicine School of the University of Lisbon

Study Record Dates

First Submitted

April 5, 2016

First Posted

April 20, 2016

Study Start

October 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

April 20, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share