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Phone Coaching and Internet-delivered Weight Loss

Primary Purpose

Obesity

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet-based weight loss program
Brief phone coaching
Extended phone coaching
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, weight loss, exercise, diet, phone coaching

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18-70
  • BMI: 25-45 kg/m2
  • Regular internet access

Exclusion Criteria:

  • 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

Sites / Locations

  • The Miriam Hospital's Weight Control and Diabetes Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Internet weight loss + possibility of brief phone coaching

Internet weight loss + possibility of extended phone coaching

Internet weight loss only

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Percent weight change at 4 months
Weight change will be assessed using weight at baseline and 4 months
Percent weight change at 12 months
Weight change will be assessed using weight at baseline and 12 months

Secondary Outcome Measures

Cost per kg of weight loss
Cost-effectiveness analyses will be completed to determine the intervention cost per kg of weight loss
Change in physical activity minutes (min/wk)
Physical activity will be assessed using accelerometers
Change in dietary intake (kcals)
Dietary intake will be assessed using self-reported kcal totals obtained from food diaries
Self-monitoring
number of days that participant self-monitored on study website
Video lesson viewing
number of video lessons viewed on study website

Full Information

First Posted
March 4, 2019
Last Updated
May 16, 2022
Sponsor
The Miriam Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03867981
Brief Title
Phone Coaching and Internet-delivered Weight Loss
Official Title
Phone Coaching and Internet-delivered Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 6, 2019 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Miriam Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, weight loss, exercise, diet, phone coaching

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
452 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet weight loss + possibility of brief phone coaching
Arm Type
Experimental
Arm Description
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.
Arm Title
Internet weight loss + possibility of extended phone coaching
Arm Type
Experimental
Arm Description
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.
Arm Title
Internet weight loss only
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based weight loss program
Intervention Description
12-month, Internet-based weight loss/maintenance program.
Intervention Type
Behavioral
Intervention Name(s)
Brief phone coaching
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Extended phone coaching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent weight change at 4 months
Description
Weight change will be assessed using weight at baseline and 4 months
Time Frame
4 months after start of weight loss program
Title
Percent weight change at 12 months
Description
Weight change will be assessed using weight at baseline and 12 months
Time Frame
12 months after start of weight loss program
Secondary Outcome Measure Information:
Title
Cost per kg of weight loss
Description
Cost-effectiveness analyses will be completed to determine the intervention cost per kg of weight loss
Time Frame
4 months and 12 months after start of weight loss program
Title
Change in physical activity minutes (min/wk)
Description
Physical activity will be assessed using accelerometers
Time Frame
4 months after study enrollment
Title
Change in dietary intake (kcals)
Description
Dietary intake will be assessed using self-reported kcal totals obtained from food diaries
Time Frame
4 months after start of weight loss program
Title
Self-monitoring
Description
number of days that participant self-monitored on study website
Time Frame
4 months after start of weight loss program
Title
Video lesson viewing
Description
number of video lessons viewed on study website
Time Frame
4 months after start of weight loss program

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-70 BMI: 25-45 kg/m2 Regular internet access Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica L Unick, PhD
Organizational Affiliation
The Miriam Hospital's Weight Control and Diabetes Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Miriam Hospital's Weight Control and Diabetes Research Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Phone Coaching and Internet-delivered Weight Loss

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