Phone Coaching and Internet-delivered Weight Loss

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Internet-based weight loss program; Behavioral: Brief phone coaching; Behavioral: Extended phone coaching

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 Type: Interventional
• Enrollment (Actual): 452
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • The Miriam Hospital's Weight Control and Diabetes Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet weight loss + possibility of brief phone coaching; 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.	Behavioral: Internet-based weight loss program; 12-month, Internet-based weight loss/maintenance program.; Behavioral: Brief phone coaching; 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.
Experimental: Internet weight loss + possibility of extended phone coaching; 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.	Behavioral: Internet-based weight loss program; 12-month, Internet-based weight loss/maintenance program.; Behavioral: Extended phone coaching; 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.
Active Comparator: Internet weight loss only; 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.	Behavioral: Internet-based weight loss program; 12-month, Internet-based weight loss/maintenance program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Weight Change at 4 Months	Weight change was assessed using weight at baseline and 4 months	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	12 months after start of weight loss program

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost of Supplemental Coaching Per kg of Weight Loss	Cost-effectiveness analyses were completed to determine the intervention cost per kg of weight loss	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.	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.	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	4 months after start of weight loss program
Video Lesson Viewing	Percentage of video lessons viewed on study website	4 months after start of weight loss program

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Jessica L Unick, PhD, The Miriam Hospital's Weight Control and Diabetes Research Center

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2019
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: March 4, 2019
• First Submitted That Met QC Criteria: March 7, 2019
• First Posted (Actual): March 8, 2019

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Obesity; exercise; weight loss; diet; phone coaching
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 1296020; 5R01DK117843 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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).
• IPD Sharing Time Frame: baseline to 12 months
• IPD Sharing Access Criteria: Requests to view or utilize de-identified, participant-level data can be sent to the Principal Investigator (Dr. Jessica Unick - junick@lifespan.org).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No