Phone Coaching and Internet-delivered Weight Loss

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phone Coaching and Internet-delivered Weight Loss

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Internet-based weight loss program
* Behavioral: Brief phone coaching
* Behavioral: Extended phone coaching


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent weight change at 4 months | Weight change will be assessed using weight at baseline and 4 months | 4 months after start of weight loss program | 
| Percent weight change at 12 months | Weight change will be 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 per kg of weight loss | Cost-effectiveness analyses will be completed to determine the intervention cost per kg of weight loss | 4 months and 12 months after start of weight loss program | 
| Change in physical activity minutes (min/wk) | Physical activity will be assessed using accelerometers | 4 months after study enrollment | 
| Change in dietary intake (kcals) | Dietary intake will be assessed using self-reported kcal totals obtained from food diaries | 4 months after start of weight loss program | 
| Self-monitoring | number of days that participant self-monitored on study website | 4 months after start of weight loss program | 
| Video lesson viewing | number of video lessons viewed on study website | 4 months after start of weight loss program | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, weight loss, exercise, diet, phone coaching