OverweightNWWNCT03528304
Native Women's Wellness: Contingency Management for Tobacco Cessation and Weight Loss
A study testing Contingency management in people with Overweight and Obese, run by Washington State University.
Trial summary
A randomized controlled trial for the efficacy of contingency management to encourage smoking cessation and weight loss. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Overweight, Obese, Smoking
- What is being tested?
- Contingency management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- 18-44 years of age
- Be of AI/AN heritage
- Current daily smoker (self reported)
- Overweight (body mass index = 25.0-29.9 kg/m2) or obese (body mass index ≥ 30 kg/m2)
- Willing and able to attend 2 study visits per week
- Willing and able to provide written informed consent
- Interested in using Nicotine Replacement Therapy during the intervention or follow up period
Who cannot join
- Pregnant, or planning to become pregnant in next 4 months
- Currently participating in a weight loss program
- Terminal (e.g., cancer) or debilitating chronic disease (e.g., progressive multiple sclerosis) that would prevent full participation
About this study
A randomized controlled trial for the efficacy of contingency management to encourage smoking cessation and weight loss.
Read the 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.
- Conditions
- Overweight, Obese, Smoking
- Being tested
- Contingency management
- Keywords
- Obesity, Overweight, Current smoker, American Indian/Alaska Native
- Medical subject headings
- Overweight, Obesity, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency managementBehavioural
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,
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Contingency management |
| Control | No intervention | Women attended clinic visits for smoking status and weight loss assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Weight loss of 1/2lb to 1lb per week
Measured: 16 weeks
Smoking Cessation
Abstain from smoking
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study startSep 2010
- Primary completionSep 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denise Dillard, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528304
- Sponsor's protocol ID
- 5U48DP001911-02
- Acronym
- NWW
- Status last verified
- Sep 2026
- First submitted
- 20 Jul 2016
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34611902
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Native Women's Wellness: Contingency Management for Tobacco Cessation and Weight Loss
- ClinicalTrials.gov ID
- NCT03528304
- Acronym / sponsor ID
- NWW / 5U48DP001911-02
- Conditions
- Overweight, Obese, Smoking
- Keywords
- Obesity, Overweight, Current smoker, American Indian/Alaska Native
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Smoking arm | Experimental | Behavioral: Contingency managementAs part of the CM intervention, women attend visits for smoking and weight loss assessment and are rewarded with prizes for abstaining from smoking. |
| Weight loss arm | Experimental | Behavioral: Contingency managementAs part of the CM intervention women attend visits for smoking and weight loss assessment and are rewarded with prizes for losing some weight. |
| Smoking and weight loss arm | Experimental | Behavioral: Contingency managementAs 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. |
| Control | No intervention | –Women attended clinic visits for smoking status and weight loss assessment. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Female
- 18-44 years of age
- Be of AI/AN heritage
- Current daily smoker (self reported)
- Overweight (body mass index = 25.0-29.9 kg/m2) or obese (body mass index ≥ 30 kg/m2)
Key exclusion criteria (3 listed)
- Pregnant, or planning to become pregnant in next 4 months
- Currently participating in a weight loss program
- Terminal (e.g., cancer) or debilitating chronic disease (e.g., progressive multiple sclerosis) that would prevent full participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contingency managementContingency 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, | Behavioural | Smoking and weight loss arm, Smoking arm, Weight loss arm |
Primary outcome
Weight Loss
Time frame: 16 weeks
Weight loss of 1/2lb to 1lb per week
Smoking Cessation
Time frame: 16 weeks
Abstain from smoking
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Derived from this study: PubMed 34611902Hartmann-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency management in people with Overweight and Obese, run by Washington State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Loss (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03528304, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.