- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03528304
Native Women's Wellness: Contingency Management for Tobacco Cessation and Weight Loss (NWW)
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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;
- Determine if women randomized to CM conditions more often quit or reduce smoking and lose weight compared to those in the control group;
- 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;
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Smoking arm
As part of the CM intervention, women attend visits for smoking and weight loss assessment and are rewarded with prizes for abstaining from smoking.
|
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,
|
Experimental: Weight loss arm
As part of the CM intervention women attend visits for smoking and weight loss assessment and are rewarded with prizes for losing some weight.
|
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,
|
Experimental: Smoking and weight loss arm
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.
|
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,
|
No Intervention: Control
Women attended clinic visits for smoking status and weight loss assessment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight Loss
Time Frame: 16 weeks
|
Weight loss of 1/2lb to 1lb per week
|
16 weeks
|
Smoking Cessation
Time Frame: 16 weeks
|
Abstain from smoking
|
16 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5U48DP001911-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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