ObesityHSNCT01510483
Clinician Promotion of Healthy Diet and Activity to Reduce Obesity Among Adolescents: HEALTHY SMILES
A study testing Obesity Prevention and Tobacco Prevention in people with Obesity, run by San Diego State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Obesity Prevention and Tobacco Prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 693 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 8-14 years old
- receiving orthodontic care at a participating orthodontic office
- at least 1 year left in braces
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
SDSU-Center for Behavioral Epidemiology & Community Health
San Diego, California, 92123
About this study
Official title: Clinician Promotion of Healthy Diet and Activity to Reduce Obesity Among Adolescents
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.
Read the detailed description
This study will test a 18-month multi-component intervention designed to increase physical activity, reduce sedentary practices and promote healthy diets among preteens who obtain orthodontic care. The intervention is based on the Behavioral Ecological Model (BEM), where interacting physiological, environmental, and cultural contingencies select behavior. This study will require five years to recruit 40 orthodontist offices, and 1700 youth, and implement an office-wide intervention for promoting healthy diet and physical activity among 8-14 yr old youth. Our primary aims are to detect a differential change in diet, physical activity and BMI in our experimental group compared to the tobacco prevention control group; to observe differential effects of the intervention between low vs. high SES; and similarly for males vs. females; to validate our primary outcome variables by contrasting them with a "gold standard"; and determine the degree to which family and peer encouragement for sedentary and high caloric diet at baseline increases the relative effect of the orthodontist intervention. Offices will be assigned at random to condition producing a 2 (experimental group) by 2 strata (low vs. high SES) by 2 strata (male vs. female) by 4 (repeated measures) experimental design. Those in the experimental condition will be exposed to the office-wide intervention for diet and activity; those in the control condition will be exposed to an office-wide intervention for tobacco prevention. 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. Measures of diet, physical activity, body composition, tobacco use, fitness and family and peer encouragement will occur at baseline, 12, 18, and 24 months. Differential change over time will be analyzed using Random Effects Multivariate modeling. Analyses will include control for office cluster effects and multivariate models will include analyses of hypothetical main effects, experimental group by time interactions, and moderating effects by inclusion of interaction terms for susceptibility by experimental condition and other possible moderators. Relevance: If successful, this study may inform policies that would promote all specialists (physicians, general dentists) to deliver brief counseling for diet and physical activity. Doing so might yield the cumulative exposure necessary to effect and sustain change in a large proportion of the preteen population.
- Conditions
- Obesity
- Being tested
- Obesity Prevention, Tobacco Prevention
- Keywords
- obesity prevention, tobacco prevention, nutrition, physical activity, sedentary activity, tobacco use, tobacco exposure, prevention, clinician intervention, preteen, adolescents
- Medical subject headings
- Obesity, Motor Activity, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obesity PreventionBehavioural
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.
Tobacco PreventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Obesity prevention | Experimental | Orthodontist promotion of physical activity and healthy diet Receives: Behavioral: Obesity Prevention |
| Tobacco prevention | Active comparator | Orthodontist promotion of tobacco and second hand smoke avoidance Receives: Behavioral: Tobacco Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2, 4, 6, 8, 10, 12, 14, 16, 18, 24 months
Secondary outcomes (3)
Change in physical and sedentary activity
Measured: Baseline, 12, 18 and 24 months
Change in dietary intake
Measured: Baseline, 12, 18 and 24 months
Change in tobacco use and exposure
Measured: Baseline, 12, 18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2012 (estimated)
- Study startJan 2010
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 693 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melbourne Hovell, San Diego State University
- Investigators
- Melbourne F Hovell, PhD, MPH, Principal investigator, SDSU/GSPH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510483
- Sponsor's protocol ID
- 5R01CA138192
- Acronym
- HS
- Status last verified
- Apr 2018
- First submitted
- 14 Nov 2011
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 8935468Hovell 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.
PubMed 9003134Wahlgren 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.
PubMed 9291217Hovell 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.
PubMed 19928484Zakarian 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.
PubMed 11072456Russos 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.
PubMed 9010897Slymen 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.
PubMed 9279608Hovell 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.
PubMed 8573357Russos 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.
PubMed 10419794Hovell MF, Jones JA, Adams MA. The feasibility and efficacy of tobacco use prevention in orthodontics. J Dent Educ. 2001 Apr;65(4):348-53.
PubMed 11336120Morrison 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.
PubMed 9315423Keating 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.
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.
PubMed 26645420Hovell 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.
PubMed 29747047
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinician Promotion of Healthy Diet and Activity to Reduce Obesity Among Adolescents
- ClinicalTrials.gov ID
- NCT01510483
- Acronym / sponsor ID
- HS / 5R01CA138192
- Conditions
- Obesity
- Keywords
- obesity prevention, tobacco prevention, nutrition, physical activity, sedentary activity, tobacco use, tobacco exposure, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 693 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 16 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will test a 18-month multi-component intervention designed to increase physical activity, reduce sedentary practices and promote healthy diets among preteens who obtain orthodontic care. The intervention is based on the Behavioral Ecological Model (BEM), where interacting physiological, environmental, and cultural contingencies select behavior. This study will require five years to recruit 40 orthodontist offices, and 1700 youth, and implement an office-wide intervention for promoting healthy diet and physical activity among 8-14 yr old youth. Our primary aims are to detect a differential change in diet, physical activity and BMI in our experimental group compared to the tobacco prevention control group; to observe differential effects of the intervention between low vs. high SES; and similarly for males vs. females; to validate our primary outcome variables by contrasting them with a "gold standard"; and determine the degree to which family and peer encouragement for sedentary and high caloric diet at baseline increases the relative effect of the orthodontist intervention. Offices will be assigned at random to condition producing a 2 (experimental group) by 2 strata (low vs. high SES) by 2 strata (male vs. female) by 4 (repeated measures) experimental design. Those in the experimental condition will be exposed to the office-wide intervention for diet and activity; those in the control condition will be exposed to an office-wide intervention for tobacco prevention. 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. Measures of diet, physical activity, body composition, tobacco use, fitness and family and peer encouragement will occur at baseline, 12, 18, and 24 months. Differential change over time will be analyzed using Random Effects Multivariate modeling. Analyses will include control for office cluster effects and multivariate models will include analyses of hypothetical main effects, experimental group by time interactions, and moderating effects by inclusion of interaction terms for susceptibility by experimental condition and other possible moderators. Relevance: If successful, this study may inform policies that would promote all specialists (physicians, general dentists) to deliver brief counseling for diet and physical activity. Doing so might yield the cumulative exposure necessary to effect and sustain change in a large proportion of the preteen population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obesity prevention | Experimental | Behavioral: Obesity PreventionOrthodontist promotion of physical activity and healthy diet |
| Tobacco prevention | Active comparator | Behavioral: Tobacco PreventionOrthodontist promotion of tobacco and second hand smoke avoidance |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 8-14 years old
- receiving orthodontic care at a participating orthodontic office
- at least 1 year left in braces
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obesity PreventionThose 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. | Behavioural | Obesity prevention |
| Tobacco PreventionThose 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. | Behavioural | Tobacco prevention |
Primary outcome
Change in Body Mass Index
Time frame: Baseline, 2, 4, 6, 8, 10, 12, 14, 16, 18, 24 months
Body Mass Index assessed at Baseline, 12 month, 18 months and 24 months; and every 6-8 weeks during intervention period.
3 secondary outcomes
Change in physical and sedentary activity
Time frame: Baseline, 12, 18 and 24 months
Change in dietary intake
Time frame: Baseline, 12, 18 and 24 months
Change in tobacco use and exposure
Time frame: Baseline, 12, 18 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Background: PubMed 8935468Hovell 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.
- Background: PubMed 9003134Hovell 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.
- Background: PubMed 9291217Wahlgren 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.
- Background: PubMed 19928484Hovell 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.
- Background: PubMed 11072456Zakarian 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.
- Background: PubMed 9010897Russos 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.
- Background: PubMed 9279608Slymen 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.
- Background: PubMed 8573357Hovell 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.
- Background: PubMed 10419794Russos 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.
- Background: PubMed 11336120Hovell MF, Jones JA, Adams MA. The feasibility and efficacy of tobacco use prevention in orthodontics. J Dent Educ. 2001 Apr;65(4):348-53.
- Background: PubMed 9315423Morrison 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.
- BackgroundKeating 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melbourne F Hovell, PhD, MPH principal investigator
SDSU/GSPH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Obesity Prevention and Tobacco Prevention in people with Obesity, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index (time frame: Baseline, 2, 4, 6, 8, 10, 12, 14, 16, 18, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01510483, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.