Overweight and ObesityNCT03739151
Passive Sensing Technology for Lapse Measurement
A study testing Behavioral Obesity Treatment in people with Overweight and Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
Behavioral obesity treatment (BOT) produces clinically significant weight loss and health benefits for many individuals with overweight/obesity and cardiovascular disease (CVD). Yet, about half of patients fall short of expected outcomes and most experience gradual weight regain, thus negating the benefits over time. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Behavioral Obesity Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2018to 15 Sep 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Overweight or obesity (body mass index 25-45 kg/m2)
- Interested and able to participate in in-person weight loss intervention
- Physician-diagnosed one or more CVD risk factors (type 2 diabetes/prediabetes, hypercholesterolemia, or hypertension).
Who cannot join
- Report health problems that preclude weight loss or physical activity
- Are currently pregnant or breastfeeding, or planning to be pregnant within the next 6 months,
- Are currently or recently (< 6 months) enrolled in a commercial weight loss program
- Have lost ≥ 5% of their initial body weight in the last 6 months
- Currently taking weight loss medication
- Have had a previous surgical procedure for weight loss
- Have a history of a clinically diagnosed eating disorder excluding Binge Eating Disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
The Miriam Hospital Weight Control and Diabetes Research Center
Providence, Rhode Island, 02909
About this study
Official title: Applying Novel Passive Sensing Technology to Target Adherence to Diet in Behavioral Obesity Treatment for Patients With Cardiovascular Disease Risk
Behavioral obesity treatment (BOT) produces clinically significant weight loss and health benefits for many individuals with overweight/obesity and cardiovascular disease (CVD). Yet, about half of patients fall short of expected outcomes and most experience gradual weight regain, thus negating the benefits over time. Lapses (i.e., self-reported eating instances that deviate from the BOT prescribed diet) could explain poor outcomes, but the behavior is understudied because it is difficult to assess in-lab and via self-report. The investigators therefore propose to study lapses using a multimethod approach with the following tools: ecological momentary assessment (EMA; repeated sampling method via mobile device), a wrist-worn device that automatically detects eating behavior and various eating characteristics (frequency, rate, and duration of eating episodes), and 24-hour dietary recalls. The investigators will recruit participants (n=40) with overweight/obesity and one additional CVD risk factor to enroll in a 12-week BOT program and an additional 12-week period of weight loss maintenance. Participants will complete a biweekly 7-day EMA protocol to self-report on eating behavior, including the occurrence of dietary lapse. Participants will continuously wear the wrist-worn ActiGraph Link to characterize eating behavior. Lastly, participants will complete 24-hour dietary recalls via structured interview (split between days with and without lapses) at 6-week intervals to measure the composition of all food and beverages consumed. This study aims to 1) identifying characteristics of lapse behavior by measuring passively-sensed timing, duration, frequency, and rate of eating amongst known lapse episodes, 2) test the association between dietary lapse frequency and weight change, and 3) estimate nutrition composition of dietary lapses. The study approach is consistent with priorities of NHLBI to optimize clinical research and diagnostic strategies to improve CVD and related risk factors.
Read the detailed description
Design and overview. This proposal adds continuous passive sensing and periodic dietary assessment to EMA to measure dietary lapses in adults with overweight/obesity and CVD risk (n=40) throughout a BOT program (12 weeks) and a period of weight loss maintenance (12 weeks). Participants will self-report via EMA on meals and snacks, indicting when dietary lapses occur. The ActiGraph Link, a wrist-worn device that can detect the motion of food being brought to the mouth, will be used to objectively detect eating characteristics. Because the composition of foods consumed during lapses is an important facet of lapse behavior that is not measured well via passive sensing or EMA, participants will complete periodic 24-hour dietary recalls via structured interview (split between days with and without lapses) to measure the composition of all food and beverages consumed. Data from the EMA, ActiGraph, and food recalls will be integrated to assess characteristics (i.e., frequency, rate, duration), estimated caloric content, and composition of dietary lapses compared to non-lapses. The study will advance the science of weight control by combining gold-standard and innovative methods to objectively measure dietary lapses and test their association with weight change in BOT.
Recruitment and Screening. Participants will be recruited on a rolling basis using advertisements in local newspapers, the study Center's website, and advertising resources available through the Miriam Hospital. The study will recruit over 12 months aiming for 4 participants per month. Interested individuals will be contacted via telephone to complete initial screening. The study procedures will be summarized, and an in-person appointment will be scheduled for additional screening and orientation. At the orientation meeting, a thorough overview of the study purpose and procedures will be provided and consent obtained. Consented individuals will be asked to complete all screening questions and measures to determine eligibility. Eligible participants will be contacted after this visit to begin treatment. Ineligible individuals will be notified accordingly and provided with referrals for BOT in the community.
The behavioral obesity treatment is described in further detail below.
Assessment schedule. Measures are described in further detail below. The primary outcome of interest, dietary lapse, will be measured on a biweekly basis throughout the 24-week study. Participants will continuously wear a wrist-watch device to passively detect eating episodes. Composition and quality of dietary intake will be measured every 6 weeks. Participants will have weight measured and wrist-watch data downloaded at each weekly appointment during the weight loss treatment phase. During the maintenance phase of treatment, participants will be asked to attend an additional appointment once per month separate from the monthly treatment visit, to initiate data downloading on the wrist-watch sensor and have weight measured.
- Conditions
- Overweight and Obesity
- Being tested
- Behavioral Obesity Treatment
- Keywords
- overweight and obesity, eating behavior, nonadherence, patient, ecological momentary assessment, passive sensing, dietary assessment
- Medical subject headings
- Overweight, Obesity, Feeding Behavior, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Obesity TreatmentBehavioural
Also called Behavioral Weight Loss
Self-monitoring. Participants will be taught to record their weight, the calories of each food item, and physical activity using a method of their choice (e.g., commercial smartphone app, paper diary). The clinician will review dietary intake and provide personalized feedback at the outset of session.
Diet. Per national guidelines for weight loss, a daily goal of 1200-1800 kcal/day will be prescribed depending on baseline weight. A Mediterranean diet will be prescribed to meet the recommended calorie goal and be consistent with dietary recommendations for CVD patients.
Exercise. Participants will be encouraged to achieve 250 minutes/week of moderate intensity activity in accordance with current national recommendations for physical activity among individuals attempting weight loss. Participants will be encouraged to gradually increase activity level to achieve approximately 50 minutes of activity over five days per week.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Obesity Treatment | Other | All participants will receive gold-standard behavioral obesity treatment Receives: Behavioral: Behavioral Obesity Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensor-based Dietary Lapse
Participants will wear a wrist-worn 9-axis accelerometer during waking hours that measures wrist-roll motion, which can objectively assess dietary lapses.
Measured: 24-week frequency of sensor-based dietary lapse
Secondary outcomes (3)
Self-reported Dietary Lapse
Lapses will be assessed via ecological momentary assessment (EMA), a repeated sampling method using electronic forms on smartphone devices.
Measured: Participants will be asked to complete 7 days of EMA on a biweekly basis for 24 weeks. Therefore, participants will complete EMA at weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, and 23.
Weight
Participants' body weight will be measured to the nearest 0.1 kg using a calibrated digital scale
Measured: Weight will be measured at each study appointment (baseline assessment, weekly for 12 weeks, and twice monthly for the subsequent 12 weeks).
Dietary Composition
Dietary composition will be assessed using 24-hour food recall method. The Nutrition Data System for Research (NDSR), a computer-based software application developed at the University of Minnesota Nutrition Coordinating Center (NCC) will facilitate the collection of recalls in a standardized fashion
Measured: Dietary composition will be assessed at baseline and at weeks 5, 11, 17, and 23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start24 Oct 2018
- Primary completion15 Sep 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants in this study receive gold-standard behavioral obesity treatment on an individual basis.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, John Graham Thomas, The Miriam Hospital
- Investigators
- Graham Thomas, PhD, Study chair, The Miriam HospitalStephanie P Goldstein, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739151
- Sponsor's protocol ID
- 1F32HL143954-01
- Status last verified
- Mar 2021
- First submitted
- 8 Nov 2018
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The raw data from the current project are too large to easily transfer to individual investigators. As such, the investigators plan to develop a cost-effective, safe plan for sharing de-identified participant data upon reasonable request by other researchers.
Publications
Goldstein SP, Olson KL, Thomas JG. Association of weight and shape concern with weight change and weight-related behaviors in behavioral weight loss treatment. J Behav Med. 2023 Dec;46(6):1049-1056. doi: 10.1007/s10865-023-00451-5. Epub 2023 Sep 23.
PubMed 37740874Goldstein SP, Hoover A, Thomas JG. Combining passive eating monitoring and ecological momentary assessment to characterize dietary lapses from a lifestyle modification intervention. Appetite. 2022 Aug 1;175:106090. doi: 10.1016/j.appet.2022.106090. Epub 2022 May 20.
PubMed 35598718Goldstein SP, Hoover A, Evans EW, Thomas JG. Combining ecological momentary assessment, wrist-based eating detection, and dietary assessment to characterize dietary lapse: A multi-method study protocol. Digit Health. 2021 Feb 2;7:2055207620988212. doi: 10.1177/2055207620988212. eCollection 2021 Jan-Dec.
PubMed 33598309
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Novel Passive Sensing Technology to Target Adherence to Diet in Behavioral Obesity Treatment for Patients With Cardiovascular Disease Risk
- ClinicalTrials.gov ID
- NCT03739151
- Acronym / sponsor ID
- 1F32HL143954-01
- Conditions
- Overweight and Obesity
- Keywords
- overweight and obesity, eating behavior, nonadherence, patient, ecological momentary assessment, passive sensing, dietary assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 13 Nov 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.
Behavioral obesity treatment (BOT) produces clinically significant weight loss and health benefits for many individuals with overweight/obesity and cardiovascular disease (CVD). Yet, about half of patients fall short of expected outcomes and most experience gradual weight regain, thus negating the benefits over time. Lapses (i.e., self-reported eating instances that deviate from the BOT prescribed diet) could explain poor outcomes, but the behavior is understudied because it is difficult to assess in-lab and via self-report. The investigators therefore propose to study lapses using a multimethod approach with the following tools: ecological momentary assessment (EMA; repeated sampling method via mobile device), a wrist-worn device that automatically detects eating behavior and various eating characteristics (frequency, rate, and duration of eating episodes), and 24-hour dietary recalls. The investigators will recruit participants (n=40) with overweight/obesity and one additional CVD risk factor to enroll in a 12-week BOT program and an additional 12-week period of weight loss maintenance. Participants will complete a biweekly 7-day EMA protocol to self-report on eating behavior, including the occurrence of dietary lapse. Participants will continuously wear the wrist-worn ActiGraph Link to characterize eating behavior. Lastly, participants will complete 24-hour dietary recalls via structured interview (split between days with and without lapses) at 6-week intervals to measure the composition of all food and beverages consumed. This study aims to 1) identifying characteristics of lapse behavior by measuring passively-sensed timing, duration, frequency, and rate of eating amongst known lapse episodes, 2) test the association between dietary lapse frequency and weight change, and 3) estimate nutrition composition of dietary lapses. The study approach is consistent with priorities of NHLBI to optimize clinical research and diagnostic strategies to improve CVD and related risk factors.
Detailed description
Design and overview. This proposal adds continuous passive sensing and periodic dietary assessment to EMA to measure dietary lapses in adults with overweight/obesity and CVD risk (n=40) throughout a BOT program (12 weeks) and a period of weight loss maintenance (12 weeks). Participants will self-report via EMA on meals and snacks, indicting when dietary lapses occur. The ActiGraph Link, a wrist-worn device that can detect the motion of food being brought to the mouth, will be used to objectively detect eating characteristics. Because the composition of foods consumed during lapses is an important facet of lapse behavior that is not measured well via passive sensing or EMA, participants will complete periodic 24-hour dietary recalls via structured interview (split between days with and without lapses) to measure the composition of all food and beverages consumed. Data from the EMA, ActiGraph, and food recalls will be integrated to assess characteristics (i.e., frequency, rate, duration), estimated caloric content, and composition of dietary lapses compared to non-lapses. The study will advance the science of weight control by combining gold-standard and innovative methods to objectively measure dietary lapses and test their association with weight change in BOT.
Recruitment and Screening. Participants will be recruited on a rolling basis using advertisements in local newspapers, the study Center's website, and advertising resources available through the Miriam Hospital. The study will recruit over 12 months aiming for 4 participants per month. Interested individuals will be contacted via telephone to complete initial screening. The study procedures will be summarized, and an in-person appointment will be scheduled for additional screening and orientation. At the orientation meeting, a thorough overview of the study purpose and procedures will be provided and consent obtained. Consented individuals will be asked to complete all screening questions and measures to determine eligibility. Eligible participants will be contacted after this visit to begin treatment. Ineligible individuals will be notified accordingly and provided with referrals for BOT in the community.
The behavioral obesity treatment is described in further detail below.
Assessment schedule. Measures are described in further detail below. The primary outcome of interest, dietary lapse, will be measured on a biweekly basis throughout the 24-week study. Participants will continuously wear a wrist-watch device to passively detect eating episodes. Composition and quality of dietary intake will be measured every 6 weeks. Participants will have weight measured and wrist-watch data downloaded at each weekly appointment during the weight loss treatment phase. During the maintenance phase of treatment, participants will be asked to attend an additional appointment once per month separate from the monthly treatment visit, to initiate data downloading on the wrist-watch sensor and have weight measured.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants in this study receive gold-standard behavioral obesity treatment on an individual basis.
| Arm | Type | Receives |
|---|---|---|
| Behavioral Obesity Treatment | Other | Behavioral: Behavioral Obesity TreatmentAll participants will receive gold-standard behavioral obesity treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Overweight or obesity (body mass index 25-45 kg/m2)
- Interested and able to participate in in-person weight loss intervention
- Physician-diagnosed one or more CVD risk factors (type 2 diabetes/prediabetes, hypercholesterolemia, or hypertension).
Key exclusion criteria (7 listed)
- Report health problems that preclude weight loss or physical activity
- Are currently pregnant or breastfeeding, or planning to be pregnant within the next 6 months,
- Are currently or recently (< 6 months) enrolled in a commercial weight loss program
- Have lost ≥ 5% of their initial body weight in the last 6 months
- Currently taking weight loss medication
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 Obesity TreatmentAlso: Behavioral Weight LossSelf-monitoring. Participants will be taught to record their weight, the calories of each food item, and physical activity using a method of their choice (e.g., commercial smartphone app, paper diary). The clinician will review dietary intake and provide personalized feedback at the outset of session. Diet. Per national guidelines for weight loss, a daily goal of 1200-1800 kcal/day will be prescribed depending on baseline weight. A Mediterranean diet will be prescribed to meet the recommended calorie goal and be consistent with dietary recommendations for CVD patients. Exercise. Participants will be encouraged to achieve 250 minutes/week of moderate intensity activity in accordance with current national recommendations for physical activity among individuals attempting weight loss. Participants will be encouraged to gradually increase activity level to achieve approximately 50 minutes of activity over five days per week. | Behavioural | Behavioral Obesity Treatment |
Primary outcome
Sensor-based Dietary Lapse
Time frame: 24-week frequency of sensor-based dietary lapse
Participants will wear a wrist-worn 9-axis accelerometer during waking hours that measures wrist-roll motion, which can objectively assess dietary lapses.
3 secondary outcomes
Self-reported Dietary Lapse
Time frame: Participants will be asked to complete 7 days of EMA on a biweekly basis for 24 weeks. Therefore, participants will complete EMA at weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, and 23.
Weight
Time frame: Weight will be measured at each study appointment (baseline assessment, weekly for 12 weeks, and twice monthly for the subsequent 12 weeks).
Dietary Composition
Time frame: Dietary composition will be assessed at baseline and at weeks 5, 11, 17, and 23
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 5 Mar 2021.
- Derived from this study: PubMed 37740874Goldstein SP, Olson KL, Thomas JG. Association of weight and shape concern with weight change and weight-related behaviors in behavioral weight loss treatment. J Behav Med. 2023 Dec;46(6):1049-1056. doi: 10.1007/s10865-023-00451-5. Epub 2023 Sep 23.
- Derived from this study: PubMed 35598718Goldstein SP, Hoover A, Thomas JG. Combining passive eating monitoring and ecological momentary assessment to characterize dietary lapses from a lifestyle modification intervention. Appetite. 2022 Aug 1;175:106090. doi: 10.1016/j.appet.2022.106090. Epub 2022 May 20.
- Derived from this study: PubMed 33598309Goldstein SP, Hoover A, Evans EW, Thomas JG. Combining ecological momentary assessment, wrist-based eating detection, and dietary assessment to characterize dietary lapse: A multi-method study protocol. Digit Health. 2021 Feb 2;7:2055207620988212. doi: 10.1177/2055207620988212. eCollection 2021 Jan-Dec.
- Individual participant dataSharing planned: Undecided. The raw data from the current project are too large to easily transfer to individual investigators. As such, the investigators plan to develop a cost-effective, safe plan for sharing de-identified participant data upon reasonable request by other researchers.
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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.
Graham Thomas, PhD study chair
The Miriam Hospital
Stephanie P Goldstein, PhD principal investigator
The Miriam Hospital
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 Obesity Treatment in people with Overweight and Obesity, run by The Miriam Hospital 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 3 inclusion and 7 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 5 Mar 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?
Sensor-based Dietary Lapse (time frame: 24-week frequency of sensor-based dietary lapse). 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 NCT03739151, which also lists 3 linked publications.
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 5 Mar 2021.