Native Women's Wellness: Contingency Management for Tobacco Cessation and Weight Loss
Condition: Overweight; Obese; Smoking
MeSH terms: Overweight; Weight Loss
Study type: Interventional

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.
    

Intervention name(s): Contingency management
Intervention type(s): Behavioral
Intervention description(s): 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,
Allocation: Randomized
Intervention model: Factorial Assignment
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.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Obesity; Overweight; Current smoker; American Indian/Alaska Native