Overweight and ObesitySWOPNCT04044794
Daily Self-Weighing for Obesity Management in Primary Care
A study testing Daily Self-Weighing in people with Overweight and Obesity, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Many adults with obesity continue to gain weight even though they do not want to. This project will test the effects of a primary care intervention in which people with obesity receive an electronic scale and recommendations to weigh themselves daily. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Daily Self-Weighing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2020to 13 Oct 2025
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 19-65 years
- Body mass index (BMI) 30 - 50 kg/m2
- Receives care at one of the participating primary care clinics
- Resides in one location at least 5 days each week
- Possesses a smartphone with data plan
- Wi-Fi or Bluetooth internet connection in home
Who cannot join
- Pregnancy or anticipating pregnancy during study duration. This is a weight loss study and weight gain/loss due to pregnancy and/or delivery would confound study results. Additionally, weight loss is not recommended for pregnant women.
- Unwilling or unable to do any of the following: give informed consent, accept random assignment, attend five measurement assessments
- Likely to relocate and no longer be seen at UAB primary care in the next 2 years
- Weight loss ≥5% of body weight in past 6 months (other than postpartum)
- Weight >180 kg (396lbs) due to the limitation of the scale being used.
- Current participation in another weight loss study
Show all 10Show fewer
- Bariatric surgery or revision in the past two years
- Prescription weight loss medications within the past 6 months
- Another household member already participating in the study
- Potential participants living farther than 50 miles driving distance from UAB will be excluded from the study. It is expected that those living farther away will be more difficult to retain as study participants.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35205
About this study
Many adults with obesity continue to gain weight even though they do not want to. This project will test the effects of a primary care intervention in which people with obesity receive an electronic scale and recommendations to weigh themselves daily. This will help us understand whether daily self-weighing might be a way to prevent continued weight gain.
- Conditions
- Overweight and Obesity
- Being tested
- Standard Care, Daily Self-Weighing
- Keywords
- weight management, body weight, behavioral, weighing
- Medical subject headings
- Overweight, Obesity, Body Weight, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard CareBehavioural
Standard care includes standardized educational materials to promote self-management of body weight along with provision of $60 for participants to purchase supplies or equipment to facilitate weight management.
Daily Self-WeighingBehavioural
Participants will receive a wireless digital scale and will be asked to keep the scale in their home, weigh daily at the same time, and view their weight trajectory on the scale's digital display.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | Participants randomly assigned to this arm will receive standardized weight management educational materials plus a monetary gift of $60 that can be used to purchase health-promoting supplies to support weight management. Receives: Behavioral: Standard Care |
| Daily Self-Weighing | Experimental | Participants randomly assigned to this arm will receive standardized weight management educational materials plus a commercially available wireless scale. Participants will be instructed to weigh daily and view their weight on the scale's digital display. Receives: Behavioral: Daily Self-Weighing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight from baseline to month 6
Body weight measured to the nearest 0.1 kg using a calibrated electronic scale
Measured: 6 months
Change in body weight from baseline to month 12
Body weight measured to the nearest 0.1 kg using a calibrated electronic scale
Measured: 12 months
Change in body weight from baseline to month 18
Body weight measured to the nearest 0.1 kg using a calibrated electronic scale
Measured: 18 months
Change in body weight from baseline to month 24
Body weight measured to the nearest 0.1 kg using a calibrated electronic scale
Measured: 24 months
Secondary outcomes (4)
Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 6
A modified version of the 23-item Weight Control Practices Survey will assess a variety of strategies for weight control, including participation in structured programs and/or self-directed weight control behaviors (e.g., reducing fat intake, maintaining food records, increasing physical activity, frequency of self-weighing). The survey measures presence and duration (in weeks) of each behavior.
Measured: baseline to month 6
Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 12
A modified version of the 23-item Weight Control Practices Survey will assess a variety of strategies for weight control, including participation in structured programs and/or self-directed weight control behaviors (e.g., reducing fat intake, maintaining food records, increasing physical activity, frequency of self-weighing). The survey measures presence and duration (in weeks) of each behavior.
Measured: month 6 to month 12
Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 18
A modified version of the 23-item Weight Control Practices Survey will assess a variety of strategies for weight control, including participation in structured programs and/or self-directed weight control behaviors (e.g., reducing fat intake, maintaining food records, increasing physical activity, frequency of self-weighing). The survey measures presence and duration (in weeks) of each behavior.
Measured: month 12 to month 18
Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 24
A modified version of the 23-item Weight Control Practices Survey will assess a variety of strategies for weight control, including participation in structured programs and/or self-directed weight control behaviors (e.g., reducing fat intake, maintaining food records, increasing physical activity, frequency of self-weighing). The survey measures presence and duration (in weeks) of each behavior.
Measured: month 18 to month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start4 Nov 2020
- Primary completion13 Oct 2025
- Study completion13 Oct 2025
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 Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, Cornell University
- Responsible party
- Principal investigator, Gareth R. Dutton PhD, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044794
- Sponsor's protocol ID
- R01DK118939
- Acronym
- SWOP
- Status last verified
- Mar 2026
- First submitted
- 2 Aug 2019
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The PI will ensure all publications that result from project-related data will comply with the NIH public access policy and develop a system by which study data may be shared with other investigators within the scientific community. With UAB IRB permission, PI may develop a de-identified database, codebook, and mechanism by which data can be shared with qualified individuals/organizations. PI will keep a record of all individuals/res. teams who request/receive a copy of the data. Interested investigators will be asked to complete a request form stating specific aims of the analyses, analytic plan, available resources, proposed timeline, and goals. PI and team will review these requests to determine whether proposed analyses constitute significant exploration of the data, team has resources to complete request, and data will be adequately protected and managed. If any issues are problematic, PI and team will attempt to negotiate a fair resolution with investigators and NIH staff.
Publications
Dutton GR, Kinsey AW, Howell CR, Pisu M, Dobelstein AE, Allison DB, Xun P, Levitsky DA, Fontaine K. The daily Self-Weighing for Obesity Management in Primary Care Study: Rationale, design and methodology. Contemp Clin Trials. 2021 Aug;107:106463. doi: 10.1016/j.cct.2021.106463. Epub 2021 May 31.
PubMed 34082075
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Self-Weighing for Obesity Management in Primary Care
- ClinicalTrials.gov ID
- NCT04044794
- Acronym / sponsor ID
- SWOP / R01DK118939
- Conditions
- Overweight and Obesity
- Keywords
- weight management, body weight, behavioral, weighing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Indiana University, Cornell University
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 13 Oct 2025 (actual)
- Study completion
- 13 Oct 2025 (actual)
- First posted
- 5 Aug 2019 (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.
Many adults with obesity continue to gain weight even though they do not want to. This project will test the effects of a primary care intervention in which people with obesity receive an electronic scale and recommendations to weigh themselves daily. This will help us understand whether daily self-weighing might be a way to prevent continued weight gain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Behavioral: Standard CareParticipants randomly assigned to this arm will receive standardized weight management educational materials plus a monetary gift of $60 that can be used to purchase health-promoting supplies to support weight management. |
| Daily Self-Weighing | Experimental | Behavioral: Daily Self-WeighingParticipants randomly assigned to this arm will receive standardized weight management educational materials plus a commercially available wireless scale. Participants will be instructed to weigh daily and view their weight on the scale's digital display. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 19-65 years
- Body mass index (BMI) 30 - 50 kg/m2
- Receives care at one of the participating primary care clinics
- Resides in one location at least 5 days each week
- Possesses a smartphone with data plan
Key exclusion criteria (10 listed)
- Pregnancy or anticipating pregnancy during study duration. This is a weight loss study and weight gain/loss due to pregnancy and/or delivery would confound study results. Additionally, weight loss is not recommended for pregnant women.
- Unwilling or unable to do any of the following: give informed consent, accept random assignment, attend five measurement assessments
- Likely to relocate and no longer be seen at UAB primary care in the next 2 years
- Weight loss ≥5% of body weight in past 6 months (other than postpartum)
- Weight >180 kg (396lbs) due to the limitation of the scale being used.
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 |
|---|---|---|
| Standard CareStandard care includes standardized educational materials to promote self-management of body weight along with provision of $60 for participants to purchase supplies or equipment to facilitate weight management. | Behavioural | Standard Care |
| Daily Self-WeighingParticipants will receive a wireless digital scale and will be asked to keep the scale in their home, weigh daily at the same time, and view their weight trajectory on the scale's digital display. | Behavioural | Daily Self-Weighing |
Primary outcome
Change in body weight from baseline to month 6
Time frame: 6 months
Body weight measured to the nearest 0.1 kg using a calibrated electronic scale
Change in body weight from baseline to month 12
Time frame: 12 months
Body weight measured to the nearest 0.1 kg using a calibrated electronic scale
Change in body weight from baseline to month 18
Time frame: 18 months
Body weight measured to the nearest 0.1 kg using a calibrated electronic scale
Change in body weight from baseline to month 24
Time frame: 24 months
Body weight measured to the nearest 0.1 kg using a calibrated electronic scale
4 secondary outcomes
Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 6
Time frame: baseline to month 6
Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 12
Time frame: month 6 to month 12
Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 18
Time frame: month 12 to month 18
Average number of weight control behaviors endorsed on the Weight Control Practices Survey at month 24
Time frame: month 18 to month 24
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 23 Mar 2026.
- Derived from this study: PubMed 34082075Dutton GR, Kinsey AW, Howell CR, Pisu M, Dobelstein AE, Allison DB, Xun P, Levitsky DA, Fontaine K. The daily Self-Weighing for Obesity Management in Primary Care Study: Rationale, design and methodology. Contemp Clin Trials. 2021 Aug;107:106463. doi: 10.1016/j.cct.2021.106463. Epub 2021 May 31.
- Individual participant dataSharing planned: Yes. The PI will ensure all publications that result from project-related data will comply with the NIH public access policy and develop a system by which study data may be shared with other investigators within the scientific community. With UAB IRB permission, PI may develop a de-identified database, codebook, and mechanism by which data can be shared with qualified individuals/organizations. PI will keep a record of all individuals/res. teams who request/receive a copy of the data. Interested investigators will be asked to complete a request form stating specific aims of the analyses, analytic plan, available resources, proposed timeline, and goals. PI and team will review these requests to determine whether proposed analyses constitute significant exploration of the data, team has resources to complete request, and data will be adequately protected and managed. If any issues are problematic, PI and team will attempt to negotiate a fair resolution with investigators and NIH staff.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Self-Weighing in people with Overweight and Obesity, run by University of Alabama at Birmingham at 1 site in United States.
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 6 inclusion and 10 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 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in body weight from baseline to month 6 (time frame: 6 months). The study lists 4 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 NCT04044794, 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 23 Mar 2026.