Clinical trial NCT03528304: Native Women's Wellness: Contingency Management for Tobacco Cessation and Weight Loss
Official title: Native Women's Wellness: Contingency Management for Tobacco Cessation and Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obese
Smoking
Keywords: Obesity
Overweight
Current smoker
American Indian/Alaska Native
Lead sponsor: Washington State University
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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.
Primary purpose: PREVENTION

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

Detailed description: American Indians and Alaska Native (AI/AN) people experience striking disparities in mortality from cardiovascular disease compared to the general U.S. population. Among women of childbearing age, early detection of chronic diseases can be missed because the type of medical care they seek is typically focused on their reproductive health care needs. Yet, chronic disease risk factors, such as smoking and obesity, are common in this age group and can be treated with evidence-based interventions.

The investigators of this study propose to implement a contingency management (CM) intervention that uses gift cards, and prizes to reinforce smoking cessation and weight loss. 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 is understudied in the treatment of obesity, and in AI/AN populations but 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, whereas a longer duration of the desired behaviors is associated with greater success in adopting permanent lifestyle change. The investigators will perform a randomized, controlled trial using a 2x2 factorial design to evaluate a 16-week culturally-tailored CM intervention that promotes cigarette cessation and weight loss among overweight/obese AI/AN women who are current smokers. Participants will be randomized to receive either: 1) CM for smoking abstinence, 2) CM for weight loss, 3) CM for both, or 4) a non-contingent control group that will not receive CM for either behavior. The specific aims are to:

1. Quantify the prevalence of overweight/obesity, smoking, high blood pressure, high cholesterol, Type 2 diabetes and/or elevated fasting blood glucose, and depression and anxiety among women of reproductive age (18-44 years) who are patients at a clinic that primarily serves AI/AN people;
2. Determine if women randomized to CM conditions more often quit or reduce smoking and lose weight compared to those in the control group;
3. Determine if the intervention is disproportionately effective for women receiving CM for both smoking abstinence and weight loss, compared to the single-behavior CM groups or the control group;
4. Quantify group differences in secondary cardiovascular disease risk factors after completing the various CM interventions.

STUDY DESIGN OVERVIEW The CM intervention is 16 weeks long and consists of four groups: 1) CM for smoking abstinence, 2) CM for weight loss, 3) CM for both, or 4) a control group that will not receive CM for either behavior. Participants will be asked to go into the clinic twice a week for 16 weeks during the intervention period, and will be asked to complete a baseline visit at the beginning of the study and three follow-up visits one month apart after the intervention is completed (weeks 20, 24, and 28). In each intervention session the women participants will complete a urine test to determine if they have smoked a cigarette within the past 3-4 days, and will be weighed on a dedicated, standardized scale. Other clinical measurements and self -reported outcomes will be collected as well.

Eligibility criteria: Inclusion Criteria:

* 1) 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.

Exclusion criteria: All other women who do not meet the inclusion criteria.

Primary outcomes:
measure: Weight Loss
timeFrame: 16 weeks
measure: Smoking Cessation
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.