Overweight and ObesitymPWRNCT04639076
Study of a Personalized vs. Standard Approach to Weight Loss Recommendations
A study testing Behavioral Weight Loss Program and Personalized Behavioral Weight Loss Program in people with Overweight and Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this study is to develop and test the feasibility of a behavioral weight loss intervention that uses personalized recommendations for diet and physical activity behaviors in a behavioral weight loss program and to explore factors associated with treatment adherence and response. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Behavioral Weight Loss Program and Personalized Behavioral Weight Loss Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2020to 10 May 2021
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 25-50 kg/m^2
- Normal or impaired glucose as determined by HbA1c fingerstick (<6.5%)
- Own an iPhone with a data and text messaging plan
- Have home Wi-Fi access
- Have the ability to read, write, and speak English
- Not meeting the American College of Sports Medicine recommendation of 150 minutes of Moderate to Vigorous Physical Activity each week
- Ability to attend 2 in-person assessment visits at the University of North Carolina (UNC) Weight Research Program clinic (at baseline and follow-up) and participate in 12 weekly remote visits with a study interventionist via phone or video call over the 12 week intervention
- Can obtain primary care provider consent that participation is appropriate if needed
Who cannot join
- Lost more than 10 pounds in the last 6 months and kept it off
- History of weight loss surgery
- Currently participating in another physical activity or weight loss program or research study that may interfere with participation in this study
- Currently meeting exercise recommendations of 150 minutes per week of moderate-to-vigorous physical activity
- Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 4 months
- Planning to relocate in the next 4 months
Show all 18Show fewer
- Cannot attend 2 in-person assessment visits at the UNC Weight Research Program clinic (at baseline and follow-up) and participate in 12 weekly remote visits with a study interventionist via phone or video call over the 12 week intervention
- Pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program, as determined by items endorsed on the Physical Activity Readiness Questionnaire (PAR-Q)
- Diagnosis of diabetes
- Taking medications to treat prediabetes
- Report taking prescription or over the counter medication with a known impact on metabolism or weight
- Current treatment for cancer
- History of clinically diagnosed eating disorder
- Diagnosis of schizophrenia or bipolar disorder
- Hospitalization for a psychiatric diagnosis within the last year
- Report a past diagnosis of or current symptoms of alcohol or substance dependence
- Unwilling or unable to wear the CGM device continuously for the duration of the study
- On dialysis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
About this study
The purpose of this study is to develop and test the feasibility of a behavioral weight loss intervention that uses personalized recommendations for diet and physical activity behaviors in a behavioral weight loss program and to explore factors associated with treatment adherence and response. The 12-week intervention will utilize digital tools for self-monitoring and counseling by weight management professionals. Exploratory analyses will be conducted to determine if there are genetic, metabolomic, microbiome, or psychosocial factors associated with treatment response.
Read the detailed description
The primary objective of the study is to test a personalized approach for prescribing weight loss strategies in overweight adults participating in a weight loss intervention and to determine if a personalized approach can optimize weight loss compared to a standard behavioral weight loss intervention. Thus, all participants will receive a behavioral weight loss intervention delivered via remote counseling and digital tools including a smart phone app, Wi-Fi- enabled smart scale, physical activity tracker. Participants in the personalized group will also use a continuous blood glucose monitoring (CGM) device.
The differences between the two groups will be the approach used to recommend diet and physical activity changes. The study will compare a Standard Behavioral Weight Loss (BWL) approach tested in numerous previous studies and consistent with current clinical practice, to a Personalized Behavioral Weight Loss (PBWL) approach that tests a combination of diet and physical activity prescriptions to determine the best "fit" for the participant. The PWBL group will actively use CGM information during the intervention period to inform diet and activity behaviors. Participants will be randomized in a 3:1 ratio to PBWL or BWL (i.e., 30 to PBWL and 10 to BWL).
- Behavioral Weight Loss: The BWL group will receive a standard weight loss intervention based on the evidence-based interventions currently being recommended for clinical practice, with general recommendations for caloric reductions based on starting weight and aimed at achieving a 1-2 lb. average weekly weight loss, and progressive weekly increases of physical activity. Supporting behavioral lessons adapted from materials used in the Diabetes Prevention Program, a landmark behavioral weight loss intervention, will also be delivered. The weight loss 'prescription' will remain consistent throughout the 3 month trial.
- Personalized Behavioral Weight Loss: The PBWL group will receive a weight loss intervention that is personalized for diet and physical activity recommendations based on a testing period where various approaches to eating and physical activity that may result in differential adherence and response are tested. Calorie recommendations will be based on measured resting energy expenditure and expected activity levels and aimed at achieving a 1-2 lb. average weekly weight loss. In the initial weeks, participants will test various diet and physical activity prescriptions. Following this period, the optimal combination will be identified by the participant, in consultation with their interventionist, based on measured blood glucose, weight loss, hunger and ability to adhere to the prescription. Diet composition (percentage of calories from fat, carbohydrates, and protein) will be personalized along with meal frequency and physical activity goals. This group will receive the same supporting behavioral lessons as the BWL group along with additional resources specific to their personalized prescription. The weight loss 'prescription' will vary across the 3-month trial based on response to treatment.
- Conditions
- Overweight and Obesity
- Being tested
- Behavioral Weight Loss Program, Personalized Behavioral Weight Loss Program
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Weight Loss ProgramBehavioural
The BWL group will receive a standard weight loss intervention based on the evidence-based interventions currently being recommended for clinical practice, with general recommendations for caloric reductions based on starting weight and progressive weekly increases of physical activity (PA). Supporting behavioral lessons based on materials used in the Diabetes Prevention Program (DPP) will also be delivered. The weight loss 'prescription' will remain consistent throughout the 3 month trial. Participants will receive digital tools including a study smart phone app that incorporates diet self-monitoring, tracking of behavioral goals, behavioral lessons and resources, and integration of data from a study-provided Wi-Fi enabled scale and physical activity tracker.
Personalized Behavioral Weight Loss ProgramBehavioural
The PBWL group will receive a calorie goal based on measured resting energy expenditure and baseline PA. In Weeks 1-4, participants will be randomly assigned to test patterns that manipulate diet composition (low-fat or low-carbohydrate), meal frequency (3 or 5-6 meals/day), and PA goals (weekly minutes or daily minutes goals). Following this period, the optimal combination will be identified by the participant and interventionist, based on weight loss, blood glucose, hunger and ability to adhere to the prescription. This group will receive the same supporting behavioral lessons as the BWL group along with additional resources specific to their personalized prescription. The weight loss 'prescription' will vary across the 3-month trial based on response to treatment. Participants will receive the same digital tools as the BWL group with resources specific to following the prescription they are following during any given program week.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Weight Loss Group | Active comparator | Participants in this arm will receive a standard behavioral weight loss approach that recommends a calorie deficit based on starting weight, a standard activity minute goal progression based on baseline activity and standard behavioral weekly counseling. Receives: Behavioral: Behavioral Weight Loss Program |
| Personalized Behavioral Weight Loss Group | Experimental | Participants in this arm will receive a personalized weight loss approach that recommends either a low carbohydrate or low fat calorie reduced diet; personalized activity plan with either daily or weekly bout-related goals; and eating frequency of either 3 times per day or 5-6 times per day. Receives: Behavioral: Personalized Behavioral Weight Loss Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight (kg)
Weight will be measured in kg on a calibrated digital scale. Greater negative changes in weight from baseline to 3 months indicate greater weight loss and better outcome.
Measured: Baseline, Month 3
Secondary outcomes (6)
Change in Body Mass Index (BMI)
BMI will be calculated using measured weight (kg) and height (m) using the formula BMI=weight (kg)/[height (m)]^2. Greater negative changes in BMI from baseline to 3 months indicate greater weight loss and better outcome.
Measured: Baseline, Month 3
Change in Visual Analog Score (VAS) for hunger and fullness
Subjective sensations of hunger will be measured using the Visual Analogue Scale (VAS) which measures sensations that range across a continuum of values. The VAS is a horizontal line measuring exactly 100 mm in length, anchored by word descriptors (i.e., 0=Not at all hungry, 100=Extremely hungry) at each end. At baseline and Month 3, participants will be asked to complete a three item VAS by placing a mark on the line at the point they feel represents their response to the question. The 3 items and anchors are 1) How hungry did you feel over the past week (0 mm anchor = not hungry at all; 100 mm anchor = extremely hungry); 2) How full did you feel after consuming meals over the past week (0 mm anchor = not full at all; 100 mm anchor = extremely full); 3) How full in general did you feel over the past week (0 mm anchor = not full at all; 100 mm anchor = extremely full). Larger positive change numbers would indicate a greater change in perceived hunger or fullness.
Measured: Baseline, Month 3
Change in dietary intake (total kcals)
The Automated Self-Administered 24 hour Dietary Assessment Tool (ASA-24) is a self-administered computer-automated 24-hour recall that will be administered on one weekend day and one week day per assessment period to estimate total calorie intake. Greater negative changes indicate reduced intake.
Measured: Baseline, Month 3
Change in dietary intake (percent kcals from carbohydrate, fat, and protein)
The Automated Self-Administered 24 hour Dietary Assessment Tool (ASA-24) is a self-administered computer-automated 24-hour recall that will be administered on one weekend day and one week day per assessment period to estimate macronutrient (% calories from carbohydrate, fat and protein) composition.
Measured: Baseline, Month 3
Change in weekly energy expenditure in kcals
The Paffenbarger questionnaire (PPAQ) assesses amount of planned and lifestyle associated physical activity performed during a typical week. The PPAQ consists of three components: (1) stair climbing, (2) walking, and (3) sports and recreation. Participants report the frequency and duration of physical activity in the past week. Scoring yields energy expenditure from physical activity per week (kcal/kg/week). Higher scores translate into greater energy expenditure per week (i.e.,better outcome). Range is 0 - no theoretical maximum.
Measured: Baseline, Month 3
Percent weight change
Percent of baseline weight lost or gained
Measured: Baseline, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start21 Oct 2020
- Primary completion10 May 2021
- Study completion10 May 2021
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 North Carolina, Chapel HillThe 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
- Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah F Tate, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639076
- Sponsor's protocol ID
- 19-2003
- Acronym
- mPWR
- Status last verified
- Dec 2020
- First submitted
- 16 Nov 2020
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martinez CE, Hatley KE, Polzien K, Diamond M, Tate DF. Testing a Personalized Behavioral Weight Loss Approach Using Multifactor Prescriptions and Self-Experimentation: 12-Week mHealth Pilot Randomized Controlled Trial Results. Obes Sci Pract. 2025 Feb 4;11(1):e70051. doi: 10.1002/osp4.70051. eCollection 2025 Feb.
PubMed 39911449
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of a Personalized vs. Standard Approach to Weight Loss Recommendations
- ClinicalTrials.gov ID
- NCT04639076
- Acronym / sponsor ID
- mPWR / 19-2003
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 10 May 2021 (actual)
- First posted
- 20 Nov 2020 (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.
The purpose of this study is to develop and test the feasibility of a behavioral weight loss intervention that uses personalized recommendations for diet and physical activity behaviors in a behavioral weight loss program and to explore factors associated with treatment adherence and response. The 12-week intervention will utilize digital tools for self-monitoring and counseling by weight management professionals. Exploratory analyses will be conducted to determine if there are genetic, metabolomic, microbiome, or psychosocial factors associated with treatment response.
Detailed description
The primary objective of the study is to test a personalized approach for prescribing weight loss strategies in overweight adults participating in a weight loss intervention and to determine if a personalized approach can optimize weight loss compared to a standard behavioral weight loss intervention. Thus, all participants will receive a behavioral weight loss intervention delivered via remote counseling and digital tools including a smart phone app, Wi-Fi- enabled smart scale, physical activity tracker. Participants in the personalized group will also use a continuous blood glucose monitoring (CGM) device.
The differences between the two groups will be the approach used to recommend diet and physical activity changes. The study will compare a Standard Behavioral Weight Loss (BWL) approach tested in numerous previous studies and consistent with current clinical practice, to a Personalized Behavioral Weight Loss (PBWL) approach that tests a combination of diet and physical activity prescriptions to determine the best "fit" for the participant. The PWBL group will actively use CGM information during the intervention period to inform diet and activity behaviors. Participants will be randomized in a 3:1 ratio to PBWL or BWL (i.e., 30 to PBWL and 10 to BWL).
- Behavioral Weight Loss: The BWL group will receive a standard weight loss intervention based on the evidence-based interventions currently being recommended for clinical practice, with general recommendations for caloric reductions based on starting weight and aimed at achieving a 1-2 lb. average weekly weight loss, and progressive weekly increases of physical activity. Supporting behavioral lessons adapted from materials used in the Diabetes Prevention Program, a landmark behavioral weight loss intervention, will also be delivered. The weight loss 'prescription' will remain consistent throughout the 3 month trial.
- Personalized Behavioral Weight Loss: The PBWL group will receive a weight loss intervention that is personalized for diet and physical activity recommendations based on a testing period where various approaches to eating and physical activity that may result in differential adherence and response are tested. Calorie recommendations will be based on measured resting energy expenditure and expected activity levels and aimed at achieving a 1-2 lb. average weekly weight loss. In the initial weeks, participants will test various diet and physical activity prescriptions. Following this period, the optimal combination will be identified by the participant, in consultation with their interventionist, based on measured blood glucose, weight loss, hunger and ability to adhere to the prescription. Diet composition (percentage of calories from fat, carbohydrates, and protein) will be personalized along with meal frequency and physical activity goals. This group will receive the same supporting behavioral lessons as the BWL group along with additional resources specific to their personalized prescription. The weight loss 'prescription' will vary across the 3-month trial based on response to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Weight Loss Group | Active comparator | Behavioral: Behavioral Weight Loss ProgramParticipants in this arm will receive a standard behavioral weight loss approach that recommends a calorie deficit based on starting weight, a standard activity minute goal progression based on baseline activity and standard behavioral weekly counseling. |
| Personalized Behavioral Weight Loss Group | Experimental | Behavioral: Personalized Behavioral Weight Loss ProgramParticipants in this arm will receive a personalized weight loss approach that recommends either a low carbohydrate or low fat calorie reduced diet; personalized activity plan with either daily or weekly bout-related goals; and eating frequency of either 3 times per day or 5-6 times per day. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- BMI 25-50 kg/m^2
- Normal or impaired glucose as determined by HbA1c fingerstick (<6.5%)
- Own an iPhone with a data and text messaging plan
- Have home Wi-Fi access
- Have the ability to read, write, and speak English
Key exclusion criteria (18 listed)
- Lost more than 10 pounds in the last 6 months and kept it off
- History of weight loss surgery
- Currently participating in another physical activity or weight loss program or research study that may interfere with participation in this study
- Currently meeting exercise recommendations of 150 minutes per week of moderate-to-vigorous physical activity
- Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 4 months
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 |
|---|---|---|
| Behavioral Weight Loss ProgramThe BWL group will receive a standard weight loss intervention based on the evidence-based interventions currently being recommended for clinical practice, with general recommendations for caloric reductions based on starting weight and progressive weekly increases of physical activity (PA). Supporting behavioral lessons based on materials used in the Diabetes Prevention Program (DPP) will also be delivered. The weight loss 'prescription' will remain consistent throughout the 3 month trial. Participants will receive digital tools including a study smart phone app that incorporates diet self-monitoring, tracking of behavioral goals, behavioral lessons and resources, and integration of data from a study-provided Wi-Fi enabled scale and physical activity tracker. | Behavioural | Behavioral Weight Loss Group |
| Personalized Behavioral Weight Loss ProgramThe PBWL group will receive a calorie goal based on measured resting energy expenditure and baseline PA. In Weeks 1-4, participants will be randomly assigned to test patterns that manipulate diet composition (low-fat or low-carbohydrate), meal frequency (3 or 5-6 meals/day), and PA goals (weekly minutes or daily minutes goals). Following this period, the optimal combination will be identified by the participant and interventionist, based on weight loss, blood glucose, hunger and ability to adhere to the prescription. This group will receive the same supporting behavioral lessons as the BWL group along with additional resources specific to their personalized prescription. The weight loss 'prescription' will vary across the 3-month trial based on response to treatment. Participants will receive the same digital tools as the BWL group with resources specific to following the prescription they are following during any given program week. | Behavioural | Personalized Behavioral Weight Loss Group |
Primary outcome
Change in weight (kg)
Time frame: Baseline, Month 3
Weight will be measured in kg on a calibrated digital scale. Greater negative changes in weight from baseline to 3 months indicate greater weight loss and better outcome.
6 secondary outcomes
Change in Body Mass Index (BMI)
Time frame: Baseline, Month 3
Change in Visual Analog Score (VAS) for hunger and fullness
Time frame: Baseline, Month 3
Change in dietary intake (total kcals)
Time frame: Baseline, Month 3
Change in dietary intake (percent kcals from carbohydrate, fat, and protein)
Time frame: Baseline, Month 3
Change in weekly energy expenditure in kcals
Time frame: Baseline, Month 3
Percent weight change
Time frame: Baseline, Month 3
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 7 Oct 2021.
- Derived from this study: PubMed 39911449Martinez CE, Hatley KE, Polzien K, Diamond M, Tate DF. Testing a Personalized Behavioral Weight Loss Approach Using Multifactor Prescriptions and Self-Experimentation: 12-Week mHealth Pilot Randomized Controlled Trial Results. Obes Sci Pract. 2025 Feb 4;11(1):e70051. doi: 10.1002/osp4.70051. eCollection 2025 Feb.
- 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.
Deborah F Tate, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Weight Loss Program and Personalized Behavioral Weight Loss Program in people with Overweight and Obesity, run by University of North Carolina, Chapel Hill 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 8 inclusion and 18 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 7 Oct 2021. 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 weight (kg) (time frame: Baseline, Month 3). 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 NCT04639076, 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 7 Oct 2021.