Native Women's Wellness: Contingency Management for Tobacco Cessation and Weight Loss

NCT03528304 | Completed

• 1 other identifier: 5U48DP001911-02
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

Brief Summary

A randomized controlled trial for the efficacy of contingency management to encourage smoking cessation and weight loss.

Conditions

Overweight; Obese; Smoking

Keywords

Obesity; Overweight; Current smoker; American Indian/Alaska Native

Outcome Measures

Primary Outcomes (2)

• Weight Loss

  Weight loss of 1/2lb to 1lb per week

  16 weeks

• Smoking Cessation

  Abstain from smoking

  16 weeks

Study Arms (4)

Smoking arm

EXPERIMENTAL

As part of the CM intervention, women attend visits for smoking and weight loss assessment and are rewarded with prizes for abstaining from smoking.

Behavioral: Contingency management

Weight loss arm

EXPERIMENTAL

As part of the CM intervention women attend visits for smoking and weight loss assessment and are rewarded with prizes for losing some weight.

Behavioral: Contingency management

Smoking and weight loss arm

EXPERIMENTAL

As part of the CM intervention, women attend visits for smoking and weight loss assessment and are rewarded with prizes for abstaining from smoking and for losing some weight.

Behavioral: Contingency management

Control

NO INTERVENTION

Women attended clinic visits for smoking status and weight loss assessment.

Interventions

Contingency management BEHAVIORAL

Contingency management (CM) is a behavioral intervention that uses gift cards, prizes, or access to privileges to reinforce specific healthy behaviors and lifestyle changes. CM has been used successfully for a range of addictive behaviors, including cigarette smoking and heroin, cocaine, methamphetamine, and other illicit substance use, as well as for reducing psychiatric problems and HIV risk. CM has great potential for treating smoking and overweight/obesity, as it reinforces both short- and long-term behaviors. This is important because both smoking cessation and weight loss are highly prone to short-term relapse,

Smoking and weight loss arm; Smoking arm; Weight loss arm

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \) female, 2) 18-44 years of age, 3) be of AI/AN heritage, 4) not pregnant, or planning to become pregnant in next 4 months, 5) current daily smoker (self reported), 6) overweight (body mass index = 25.0-29.9 kg/m2) or obese (body mass index ≥ 30 kg/m2), 7) not currently participating in a weight loss program, 8) not interested in using Nicotine Replacement Therapy during the intervention or follow up period, 9) no terminal (e.g., cancer) or debilitating chronic disease (e.g., progressive multiple sclerosis) that would prevent full participation, 10) willing and able to attend 2 study visits per week, 11) willing and able to provide written informed consent.

Sponsors & Collaborators

• Washington State University: lead

Related Publications (1)

• 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

MeSH Terms

Conditions

Overweight; Obesity; Smoking

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: We used a 2x2 factorial design to evaluate contingency management (CM) for weight loss and smoking abstinence among women who were both overweight/obese and current smokers. Participants were accordingly randomized in equal numbers into one of four groups: 1) women receiving CM for weight loss, 2) women receiving CM for smoking abstinence, 3) women receiving CM for both weight loss and smoking abstinence, or 4) a non-contingent control group.

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: May 17, 2018
• Study Start: September 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: January 1, 2015
• Last Updated: May 17, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share