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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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:

  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.

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 groups in NCT03528304
Study groupRoleWhat they receive
Smoking armExperimentalAs 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 armExperimentalAs 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 armExperimentalAs 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
ControlNo interventionWomen 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.

  1. Weight Loss

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

    Measured: 16 weeks

  2. 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.

  1. First posted17 May 2018
  2. Study startSep 2010
  3. Primary completionSep 2014
  4. Study completionJan 2015

Resources

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)
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

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.

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