Phone Coaching and Internet-delivered Weight Loss

Not Applicable

Completed

Conditions: Obesity

Interventions: Behavioral: Internet-based weight loss program
Behavioral: Extended phone coaching
Behavioral: Brief phone coaching

Registration Number: NCT03867981

Lead Sponsor: The Miriam Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 452

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internet weight loss + possibility of brief phone coaching	Internet-based weight loss program	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.
Internet weight loss + possibility of extended phone coaching	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.
Internet weight loss only	Internet-based weight loss program	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.
Internet weight loss + possibility of extended phone coaching	Internet-based weight loss program	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.
Internet weight loss + possibility of brief phone coaching	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.

Primary Outcome Measures

Name	Time	Method
Percent Weight Change at 12 Months	12 months after start of weight loss program	Weight change was assessed using weight at baseline and 12 months
Percent Weight Change at 4 Months	4 months after start of weight loss program	Weight change was assessed using weight at baseline and 4 months

Secondary Outcome Measures

Name	Time	Method
Cost of Supplemental Coaching Per kg of Weight Loss	12 months after start of weight loss program	Cost-effectiveness analyses were completed to determine the intervention cost per kg of weight loss
Self-monitoring of Calorie Intake	4 months after start of weight loss program	Percentage of days that participant self-monitored their calorie intake on study website
Change in Dietary Intake (Kcals)	4 months after start of weight loss program	Dietary intake was assessed using self-reported kcal totals obtained from food diaries. The change was calculated from baseline to 4 months.
Change in Physical Activity Minutes (Min/wk)	4 months after study enrollment	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.
Video Lesson Viewing	4 months after start of weight loss program	Percentage of video lessons viewed on study website