Treating Adults at Risk for Weight Gain With Interactive Technology

NCT01199185 | Unknown Phase 3 DMC

• 1 other identifier: 1U01HL096628
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity represents a chronic disease associated with significant cardiovascular disease (CVD) morbidity and mortality. Weight gain in young adults adversely impacts the development of CVD risk factors. Further, there is a clear relationship between weight loss in obese persons and reduction in these CVD risk factors. Unfortunately, young adults are at high risk for weight gain. Although the scientific literature contains a number of reports regarding successful weight loss efficacy studies, young adults are typically underrepresented. Cigarette smoking is the leading preventable cause of morbidity and mortality, but quitting smoking frequently results in significant weight gain. Proactive tobacco quit lines using behavioral smoking cessation interventions combined with nicotine replacement therapy (NRT) have been shown to help persons quit smoking. However, concerns about post-cessation weight gain have been reported as a significant barrier to quitting for many smokers particularly young adults. If an efficacious behavioral weight loss program could be combined with an efficacious behavioral smoking cessation program that prevented or significantly attenuated post-cessation weight gain, then a large public health benefit may result. Such a combined weight loss/ weight gain prevention / smoking cessation program that used targeted intervention strategies to young adults, removed barriers to participation, and utilize interactive technology should be appealing to this age group. To date such a combined program has not been tested in young adult cigarette smokers. Therefore, the objective of this clinical trial is to develop and test a behavioral weight loss / weight gain prevention intervention delivered through interactive technology that can be used in conjunction with an efficacious tobacco quit line. A total of 330 participants will be necessary to adequately address the following specific aims.

Conditions

Smoking; Body Weight

Outcome Measures

Primary Outcomes (1)

• Body Mass Index

  24 months after randomization

Secondary Outcomes (1)

• Smoking status

  24 months after randomization

Study Arms (2)

Tobacco Quitline Group

ACTIVE COMPARATOR

Behavioral: Smoking Cessation

Tobacco Quitline plus Interactive Technology Group

EXPERIMENTAL

Behavioral: Smoking Cessation plus Weight Loss

Interventions

Smoking Cessation BEHAVIORAL

All participants will receive a smoking cessation intervention via the Proactive TARGIT Quit Line. Participants will receive access to the TARGIT Smoking Cessation Handbook which will be a useful tool to guide them through the quitting process and highlight the major points reviewed in all counseling sessions. As part of TARGIT all participants will receive nicotine replacement therapy (NRT).

Tobacco Quitline Group

Smoking Cessation plus Weight Loss BEHAVIORAL

All participants will receive a smoking cessation intervention via the Proactive TARGIT Quit Line. Participants will receive access to the TARGIT Smoking Cessation Handbook which will be a useful tool to guide them through the quitting process and highlight the major points reviewed in all counseling sessions. As part of TARGIT all participants will receive nicotine replacement therapy (NRT). Participants in the Intervention Group will also receive a Behavioral Weight Loss/ Weight Gain Prevention Intervention delivered via interactive technology. The Intervention group will receive 16 weekly webinar sessions beginning 7 weeks after randomization via Cisco WebEx. The webinar sessions will present the behavioral weight loss/ weight gain prevention program. After the 16 weekly sessions, the webinar sessions will then be scheduled monthly for the next 6 months then quarterly thereafter for 12 months.

Tobacco Quitline plus Interactive Technology Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• \*18 to 35 years old
• BMI \> 22 kg / m2
• Self report smoking \> 10 cigarettes each day
• Have access to a telephone and the internet
• Demonstrate ability to access a specific web site
• Demonstrate ability to receive and respond to email
• Willing to accept random assignment
• \*Intending to be available for a 24 month intervention
• \*At risk for weight gain (e.g. plan to quit smoking)
• Persons will be excluded from the TARGIT study for the following:
• \*Current participation in a commercial weight loss program (e.g. Weight Watchers, Jenny Craig, etc.), current use of a prescription weight loss medication, planned weight loss surgery within the next 24 months (e.g. gastric bypass, lap band, or liposuction), current or planned enrollment in another diet / physical activity / weight loss study
• Currently meet recommendations for physical activity (i.e., 30 minutes or more of moderate physical activity per day on the majority of days each week - 150 minutes or more each week)
• \*History of cerebral, coronary, or peripheral vascular disease, or serious uncontrolled cardiac arrhythmia, revascularization procedure or uncontrolled congestive heart failure in the past 6 months
• Current substance abuse (includes alcohol use in excess of 21 drinks a week)
• Uncontrolled hypertension as defined as BP \> 140/90 mm Hg

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

Department of Preventive Medicine

Memphis, Tennessee, 38163, United States

Location

Related Publications (2)

• Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.

  PMID: 34611902 DERIVED

• Johnson KC, Thomas F, Richey P, Tran QT, Tylavsky F, Miro D, Coday M. The Primary Results of the Treating Adult Smokers at Risk for Weight Gain with Interactive Technology (TARGIT) Study. Obesity (Silver Spring). 2017 Oct;25(10):1691-1698. doi: 10.1002/oby.21968.

  PMID: 28948720 DERIVED

MeSH Terms

Conditions

Smoking; Body Weight

Condition Hierarchy (Ancestors)

Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen Johnson, MD, MPH

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 10, 2010
• Study Start: August 1, 2009
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: June 18, 2013

Record last verified: 2013-06

Locations

US (1)