Clinician Promotion of Healthy Diet and Activity to Reduce Obesity Among Adolescents: HEALTHY SMILES

NCT01510483 | Completed DMC

• 1 other identifier: 5R01CA138192
• Study Type: interventional
• Target: 693
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test an 18-month intervention designed to increase physical activity, reduce sedentary practices and promote healthy diets or reduce tobacco use and exposure among preteens who obtain orthodontic care. Relevance: If successful, this study may inform policies that would promote all specialists (orthodontists, physicians, general dentists) to deliver brief counseling for diet, physical activity, and tobacco prevention.

Conditions

Obesity

Keywords

obesity prevention; tobacco prevention; nutrition; physical activity; sedentary activity; tobacco use; tobacco exposure; prevention; clinician intervention; preteen; adolescents

Outcome Measures

Primary Outcomes (1)

• Change in Body Mass Index

  Body Mass Index assessed at Baseline, 12 month, 18 months and 24 months; and every 6-8 weeks during intervention period.

  Baseline, 2, 4, 6, 8, 10, 12, 14, 16, 18, 24 months

Secondary Outcomes (3)

• Change in physical and sedentary activity

  Baseline, 12, 18 and 24 months

• Change in dietary intake

  Baseline, 12, 18 and 24 months

• Change in tobacco use and exposure

  Baseline, 12, 18 and 24 months

Study Arms (2)

Obesity prevention

EXPERIMENTAL

Orthodontist promotion of physical activity and healthy diet

Behavioral: Obesity Prevention

Tobacco prevention

ACTIVE COMPARATOR

Orthodontist promotion of tobacco and second hand smoke avoidance

Behavioral: Tobacco Prevention

Interventions

Obesity Prevention BEHAVIORAL

Those in the experimental, obesity prevention, condition will be exposed to the office-wide intervention for diet and activity. The intervention will consist of training of orthodontists and office staff to provide appropriate social prompts, reinforcement and counseling, and modification of the offices to provide supportive physical and social resources for their patients and parents.

Obesity prevention

Tobacco Prevention BEHAVIORAL

Those in the control, tobacco prevention, condition will be exposed to the office-wide intervention for avoidance of tobacco and second hand smoke. The intervention will consist of training of orthodontists and office staff to provide appropriate social prompts, reinforcement and counseling, and modification of the offices to provide supportive physical and social resources for their patients and parents.

Tobacco prevention

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years old
• receiving orthodontic care at a participating orthodontic office
• at least 1 year left in braces

You may not qualify if:

• participating in 9 or more months of structured
• organized sports for 3 or more days a week, youth who have serious conditions that preclude physical activity or make the child incapable of managing his/her own care will not qualify for this study
• individuals who report anorexia, bulimia or severe, diagnosed depression will not be eligible

Sponsors & Collaborators

• San Diego State University: lead

Study Sites (1)

SDSU-Center for Behavioral Epidemiology & Community Health

San Diego, California, 92123, United States

Location

Related Publications (14)

• Hovell MF, Slymen DJ, Keating KJ, Jones JA, Burkham-Kreitner S, Hofstetter CR, Noel D, Rubin B. Tobacco use prevalence and correlates among adolescents in a clinician initiated tobacco prevention trial in California, USA. J Epidemiol Community Health. 1996 Jun;50(3):340-6. doi: 10.1136/jech.50.3.340.

  PMID: 8935468 BACKGROUND

• Hovell MF, Slymen DJ, Jones JA, Hofstetter CR, Burkham-Kreitner S, Conway TL, Rubin B, Noel D. An adolescent tobacco-use prevention trial in orthodontic offices. Am J Public Health. 1996 Dec;86(12):1760-6. doi: 10.2105/ajph.86.12.1760.

  PMID: 9003134 BACKGROUND

• Wahlgren DR, Hovell MF, Slymen DJ, Conway TL, Hofstetter CR, Jones JA. Predictors of tobacco use initiation in adolescents: a two-year prospective study and theoretical discussion. Tob Control. 1997 Summer;6(2):95-103. doi: 10.1136/tc.6.2.95.

  PMID: 9291217 BACKGROUND

• Hovell MF, Nichols JF, Irvin VL, Schmitz KE, Rock CL, Hofstetter CR, Keating K, Stark LJ. Parent/Child training to increase preteens' calcium, physical activity, and bone density: a controlled trial. Am J Health Promot. 2009 Nov-Dec;24(2):118-28. doi: 10.4278/ajhp.08021111.

  PMID: 19928484 BACKGROUND

• Zakarian JM, Hovell MF, Conway TL, Hofstetter CR, Slymen DJ. Tobacco use and other risk behaviors: cross-sectional and predictive relationships for adolescent orthodontic patients. Nicotine Tob Res. 2000 May;2(2):179-86. doi: 10.1080/713688132.

  PMID: 11072456 BACKGROUND

• Russos S, Hovell MF, Keating K, Jones JA, Burkham SM, Slymen DJ, Hofstetter CR, Rubin B. Clinician compliance with primary prevention of tobacco use: the impact of social contingencies. Prev Med. 1997 Jan-Feb;26(1):44-52. doi: 10.1006/pmed.1996.9994.

  PMID: 9010897 BACKGROUND

• Slymen DJ, Hovell MF. Cluster versus individual randomization in adolescent tobacco and alcohol studies: illustrations for design decisions. Int J Epidemiol. 1997 Aug;26(4):765-71. doi: 10.1093/ije/26.4.765.

  PMID: 9279608 BACKGROUND

• Hovell MF, Russos S, Beckhelm MK, Jones JA, Burkham-Kreitner SM, Slymen DJ, Hofstetter CR, Rubin B. Compliance with primary prevention in private practice: creating a tobacco-free environment. Am J Prev Med. 1995 Sep-Oct;11(5):288-93.

  PMID: 8573357 BACKGROUND

• Russos S, Keating K, Hovell MF, Jones JA, Slymen DJ, Hofstetter CR, Rubin B, Morrison T. Counseling youth in tobacco-use prevention: determinants of clinician compliance. Prev Med. 1999 Jul;29(1):13-21. doi: 10.1006/pmed.1999.0495.

  PMID: 10419794 BACKGROUND

• Hovell MF, Jones JA, Adams MA. The feasibility and efficacy of tobacco use prevention in orthodontics. J Dent Educ. 2001 Apr;65(4):348-53.

  PMID: 11336120 BACKGROUND

• Morrison TC, Wahlgren DR, Hovell MF, Zakarian J, Burkham-Kreitner S, Hofstetter CR, Slymen DJ, Keating K, Russos S, Jones JA. Tracking and follow-up of 16,915 adolescents: minimizing attrition bias. Control Clin Trials. 1997 Oct;18(5):383-96. doi: 10.1016/s0197-2456(97)00025-1.

  PMID: 9315423 BACKGROUND

• Keating KJ, Russos S, Hovell MF, Jones JA, Wahlgren D. Creating tobacco-free environments in clinicians' offices: Do patients notice? J Health Educ 2000;31(1):37-41.

  BACKGROUND

• Cisse-Egbuonye N, Liles S, Schmitz KE, Kassem N, Irvin VL, Hovell MF. Availability of Vending Machines and School Stores in California Schools. J Sch Health. 2016 Jan;86(1):48-53. doi: 10.1111/josh.12349.

  PMID: 26645420 RESULT

• Hovell MF, Schmitz KE, Liles S, Robusto K, Hofstetter CR, Nichols JF, Rock CL, Irvin V, Parker MS, Surillo SA, Noel D. A randomized controlled trial of orthodontist-based brief advice to prevent child obesity. Contemp Clin Trials. 2018 Jul;70:53-61. doi: 10.1016/j.cct.2018.05.003. Epub 2018 May 7.

  PMID: 29747047 DERIVED

MeSH Terms

Conditions

Obesity; Motor Activity; Tobacco Use

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Melbourne F Hovell, PhD, MPH

  SDSU/GSPH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of CBEACH, Distinguished Professor of Public Health

Study Record Dates

• First Submitted: November 14, 2011
• First Posted: January 16, 2012
• Study Start: January 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

US (1)