ObesityNCT03867981
Phone Coaching and Internet-delivered Weight Loss
A study testing Internet-based weight loss program, Brief phone coaching and Extended phone coaching in people with Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
The purpose of this study is to examine whether adding phone coaching to an Internet-based weight loss program can improve weight loss outcomes at 4 months and 1 year. All individuals will receive a 4-month, Internet-delivered weight loss program followed by an 8-month Internet-delivered weight loss maintenance… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Internet-based weight loss program, Brief phone coaching and Extended phone coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2019to 1 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-70
- BMI: 25-45 kg/m2
- Regular internet access
Who cannot join
- Currently pregnant, <6 months post-partum, nursing, or planning to become pregnant within the next 12 months.
- Current enrollment in a commercial weight loss program or other weight loss research study
- Currently taking weight loss medications
- Previously had bariatric surgery
- Inability to walk 2 blocks without stopping
- Any medical condition for which weight loss, dietary restriction, or physical activity is contraindicated
Trial locations and contacts
1 site in 1 country.
United States1 site
The Miriam Hospital's Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
About this study
The purpose of this study is to examine whether adding phone coaching to an Internet-based weight loss program can improve weight loss outcomes at 4 months and 1 year. All individuals will receive a 4-month, Internet-delivered weight loss program followed by an 8-month Internet-delivered weight loss maintenance program. Some individuals will also be selected to receive either 3 weeks or 12 weeks of phone coaching. Assessments of weight, diet, physical activity, and psychosocial factors will occur at baseline, 4 months, and 1 year.
Read the detailed description
All individuals enrolled in this study will receive a 4-month Internet-based weight loss program followed by an 8-month Internet-based weight loss maintenance program. During the first 4 months, each week individuals will be asked to view a 10-15-minute multi-media lesson (one per week). These lessons focus on behavioral principles for changing diet and physical activity behaviors. Participants are also given weight loss, calorie intake, and physical activity goals. They are taught how to self-monitor this information and are instructed to submit it weekly on the study website. Automated, weekly individualized feedback is provided. Following the 4-month weight loss program participants will receive an 8-month weight loss maintenance program. During this time, they will be asked to view monthly video lessons which focus on strategies for successful WL maintenance and instructed to continue to self-monitor weight, calorie intake, and physical activity minutes on the study website for one week per month. Automated, monthly feedback is provided.
In addition to the Internet program described above, some individuals enrolled in this study will be selected to receive phone coaching. Those selected for 'brief' phone coaching will be asked to complete 3 phone calls with a coach between weeks 5-8 of the study and those selected to receive 'extended' phone coaching will be asked to complete 12 phone calls with a coach between weeks 5-16. The first coaching call will be approximately 45 minutes in duration and all subsequent calls will be approximately 15 minutes in duration. The coach will assist participants in developing a meal plan, problem solving around current barriers, and goal setting. Upon completion of all coaching calls participants will have no additional interaction with the coach, but will remain enrolled in the Internet program.
Assessments will occur at baseline, 4, and 12 months.
- Conditions
- Obesity
- Being tested
- Internet-based weight loss program, Brief phone coaching, Extended phone coaching
- Keywords
- Obesity, weight loss, exercise, diet, phone coaching
- Medical subject headings
- Obesity, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based weight loss programBehavioural
12-month, Internet-based weight loss/maintenance program.
Brief phone coachingBehavioural
Some individuals will receive 3 weeks of phone coaching. Coaching calls will occur 1x/week, starting at week 5. Once coaching calls are completed, the participant will not have any other contact with their coach.
Extended phone coachingBehavioural
Some individuals will receive 12 weeks of phone coaching. Coaching calls will occur 1x/week, starting at week 5. Once coaching calls are completed, the participant will not have any other contact with their coach.
| Study group | Role | What they receive |
|---|---|---|
| Internet weight loss + possibility of brief phone coaching | Experimental | Participants randomized to this group will receive a 4-month, Internet-delivered weight loss program followed by an 8-month, Internet-delivered weight loss maintenance program. All individuals will be taught behavioral strategies for changing diet and physical activity behaviors via video lessons. Some participants in this group will also be selected to receive a brief period (i.e., once/week for 3 weeks) of phone coaching starting at week 5. The first coaching call will be approximately 45 minutes in duration and remaining calls with be 10-15 minutes. Coaches will problem solve with participants and help them develop an individualized meal plan. Receives: Behavioral: Internet-based weight loss program; Behavioral: Brief phone coaching |
| Internet weight loss + possibility of extended phone coaching | Experimental | Participants randomized to this group will receive a 4-month, Internet-delivered weight loss program followed by an 8-month, Internet-delivered weight loss maintenance program. All individuals will be taught behavioral strategies for changing diet and physical activity behaviors via video lessons. Some participants in this group will also be selected to receive an extended period (i.e., once/week for 12 weeks) of phone coaching starting at week 5. The first coaching call will be approximately 45 minutes in duration and remaining calls with be 10-15 minutes. Coaches will problem solve with participants and help them develop an individualized meal plan. Receives: Behavioral: Internet-based weight loss program; Behavioral: Extended phone coaching |
| Internet weight loss only | Active comparator | Participants randomized to this group will receive a 4-month, Internet-delivered weight loss program followed by an 8-month, Internet-delivered weight loss maintenance program. All individuals will be taught behavioral strategies for changing diet and physical activity behaviors via video lessons. No participants in this group will receive any phone coaching. Receives: Behavioral: Internet-based weight loss program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Weight Change at 4 Months
Weight change was assessed using weight at baseline and 4 months
Measured: 4 months after start of weight loss program
Percent Weight Change at 12 Months
Weight change was assessed using weight at baseline and 12 months
Measured: 12 months after start of weight loss program
Secondary outcomes (5)
Cost of Supplemental Coaching Per kg of Weight Loss
Cost-effectiveness analyses were completed to determine the intervention cost per kg of weight loss
Measured: 12 months after start of weight loss program
Change in Physical Activity Minutes (Min/wk)
Physical activity was assessed via Actigraph accelerometers and included moderate-to-vigorous physical activity that was accumulated in bouts of >=10 minutes. A change score between baseline and 4 months was calculated.
Measured: 4 months after study enrollment
Change in Dietary Intake (Kcals)
Dietary intake was assessed using self-reported kcal totals obtained from food diaries. The change was calculated from baseline to 4 months.
Measured: 4 months after start of weight loss program
Self-monitoring of Calorie Intake
Percentage of days that participant self-monitored their calorie intake on study website
Measured: 4 months after start of weight loss program
Video Lesson Viewing
Percentage of video lessons viewed on study website
Measured: 4 months after start of weight loss program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start6 Mar 2019
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica L Unick, PhD, Principal investigator, The Miriam Hospital's Weight Control and Diabetes Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867981
- Sponsor's protocol ID
- 1296020
- Other IDs
- 5R01DK117843
- Status last verified
- Apr 2022
- First submitted
- 4 Mar 2019
- Last updated
- 17 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol, statistical analysis plan, and informed consent document can be found within this clinicaltrials.gov record. Requests to view or utilize de-identified, participant-level data can be sent to the Principal Investigator (Dr. Jessica Unick - junick@lifespan.org).
Publications
Unick JL, Pellegrini CA, Dunsiger SI, Demos KE, Thomas JG, Bond DS, Lee RH, Webster J, Wing RR. An Adaptive Telephone Coaching Intervention for Patients in an Online Weight Loss Program: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2414587. doi: 10.1001/jamanetworkopen.2024.14587.
PubMed 38848067
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phone Coaching and Internet-delivered Weight Loss
- ClinicalTrials.gov ID
- NCT03867981
- Acronym / sponsor ID
- 1296020
- Conditions
- Obesity
- Keywords
- Obesity, weight loss, exercise, diet, phone coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 8 Mar 2019 (actual)
- Results
- Posted 17 Jul 2024
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 examine whether adding phone coaching to an Internet-based weight loss program can improve weight loss outcomes at 4 months and 1 year. All individuals will receive a 4-month, Internet-delivered weight loss program followed by an 8-month Internet-delivered weight loss maintenance program. Some individuals will also be selected to receive either 3 weeks or 12 weeks of phone coaching. Assessments of weight, diet, physical activity, and psychosocial factors will occur at baseline, 4 months, and 1 year.
Detailed description
All individuals enrolled in this study will receive a 4-month Internet-based weight loss program followed by an 8-month Internet-based weight loss maintenance program. During the first 4 months, each week individuals will be asked to view a 10-15-minute multi-media lesson (one per week). These lessons focus on behavioral principles for changing diet and physical activity behaviors. Participants are also given weight loss, calorie intake, and physical activity goals. They are taught how to self-monitor this information and are instructed to submit it weekly on the study website. Automated, weekly individualized feedback is provided. Following the 4-month weight loss program participants will receive an 8-month weight loss maintenance program. During this time, they will be asked to view monthly video lessons which focus on strategies for successful WL maintenance and instructed to continue to self-monitor weight, calorie intake, and physical activity minutes on the study website for one week per month. Automated, monthly feedback is provided.
In addition to the Internet program described above, some individuals enrolled in this study will be selected to receive phone coaching. Those selected for 'brief' phone coaching will be asked to complete 3 phone calls with a coach between weeks 5-8 of the study and those selected to receive 'extended' phone coaching will be asked to complete 12 phone calls with a coach between weeks 5-16. The first coaching call will be approximately 45 minutes in duration and all subsequent calls will be approximately 15 minutes in duration. The coach will assist participants in developing a meal plan, problem solving around current barriers, and goal setting. Upon completion of all coaching calls participants will have no additional interaction with the coach, but will remain enrolled in the Internet program.
Assessments will occur at baseline, 4, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Internet weight loss + possibility of brief phone coaching | Experimental | Behavioral: Internet-based weight loss program, Behavioral: Brief phone coachingParticipants randomized to this group will receive a 4-month, Internet-delivered weight loss program followed by an 8-month, Internet-delivered weight loss maintenance program. All individuals will be taught behavioral strategies for changing diet and physical activity behaviors via video lessons. Some participants in this group will also be selected to receive a brief period (i.e., once/week for 3 weeks) of phone coaching starting at week 5. The first coaching call will be approximately 45 minutes in duration and remaining calls with be 10-15 minutes. Coaches will problem solve with participants and help them develop an individualized meal plan. |
| Internet weight loss + possibility of extended phone coaching | Experimental | Behavioral: Internet-based weight loss program, Behavioral: Extended phone coachingParticipants randomized to this group will receive a 4-month, Internet-delivered weight loss program followed by an 8-month, Internet-delivered weight loss maintenance program. All individuals will be taught behavioral strategies for changing diet and physical activity behaviors via video lessons. Some participants in this group will also be selected to receive an extended period (i.e., once/week for 12 weeks) of phone coaching starting at week 5. The first coaching call will be approximately 45 minutes in duration and remaining calls with be 10-15 minutes. Coaches will problem solve with participants and help them develop an individualized meal plan. |
| Internet weight loss only | Active comparator | Behavioral: Internet-based weight loss programParticipants randomized to this group will receive a 4-month, Internet-delivered weight loss program followed by an 8-month, Internet-delivered weight loss maintenance program. All individuals will be taught behavioral strategies for changing diet and physical activity behaviors via video lessons. No participants in this group will receive any phone coaching. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-70
- BMI: 25-45 kg/m2
- Regular internet access
Key exclusion criteria (6 listed)
- Currently pregnant, <6 months post-partum, nursing, or planning to become pregnant within the next 12 months.
- Current enrollment in a commercial weight loss program or other weight loss research study
- Currently taking weight loss medications
- Previously had bariatric surgery
- Inability to walk 2 blocks without stopping
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 |
|---|---|---|
| Internet-based weight loss program12-month, Internet-based weight loss/maintenance program. | Behavioural | Internet weight loss + possibility of brief phone coaching, Internet weight loss + possibility of extended phone coaching, Internet weight loss only |
| Brief phone coachingSome individuals will receive 3 weeks of phone coaching. Coaching calls will occur 1x/week, starting at week 5. Once coaching calls are completed, the participant will not have any other contact with their coach. | Behavioural | Internet weight loss + possibility of brief phone coaching |
| Extended phone coachingSome individuals will receive 12 weeks of phone coaching. Coaching calls will occur 1x/week, starting at week 5. Once coaching calls are completed, the participant will not have any other contact with their coach. | Behavioural | Internet weight loss + possibility of extended phone coaching |
Primary outcome
Percent Weight Change at 4 Months
Time frame: 4 months after start of weight loss program
Weight change was assessed using weight at baseline and 4 months
Percent Weight Change at 12 Months
Time frame: 12 months after start of weight loss program
Weight change was assessed using weight at baseline and 12 months
5 secondary outcomes
Cost of Supplemental Coaching Per kg of Weight Loss
Time frame: 12 months after start of weight loss program
Change in Physical Activity Minutes (Min/wk)
Time frame: 4 months after study enrollment
Change in Dietary Intake (Kcals)
Time frame: 4 months after start of weight loss program
Self-monitoring of Calorie Intake
Time frame: 4 months after start of weight loss program
Video Lesson Viewing
Time frame: 4 months after start of weight loss program
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38848067Unick JL, Pellegrini CA, Dunsiger SI, Demos KE, Thomas JG, Bond DS, Lee RH, Webster J, Wing RR. An Adaptive Telephone Coaching Intervention for Patients in an Online Weight Loss Program: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2414587. doi: 10.1001/jamanetworkopen.2024.14587.
- Individual participant dataSharing planned: Yes. Study protocol, statistical analysis plan, and informed consent document can be found within this clinicaltrials.gov record. Requests to view or utilize de-identified, participant-level data can be sent to the Principal Investigator (Dr. Jessica Unick - junick@lifespan.org).
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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.
Jessica L Unick, PhD principal investigator
The Miriam Hospital's Weight Control and Diabetes Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based weight loss program, Brief phone coaching and Extended phone coaching in people with 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 6 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 17 Jul 2024. 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?
Yes. Results are posted in the registry (first posted 17 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Weight Change at 4 Months (time frame: 4 months after start of weight loss program). 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 NCT03867981, 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 17 Jul 2024.