Clinical trial NCT03867981: Phone Coaching and Internet-delivered Weight Loss
Official title: Phone Coaching and Internet-delivered Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
weight loss
exercise
diet
phone coaching
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-03-08
Enrollment: 452
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percent Weight Change at 4 Months
timeFrame: 4 months after start of weight loss program
measure: Percent Weight Change at 12 Months
timeFrame: 12 months after start of weight loss program
Secondary outcomes:
measure: Cost of Supplemental Coaching Per kg of Weight Loss
timeFrame: 12 months after start of weight loss program
measure: Change in Physical Activity Minutes (Min/wk)
timeFrame: 4 months after study enrollment
measure: Change in Dietary Intake (Kcals)
timeFrame: 4 months after start of weight loss program
measure: Self-monitoring of Calorie Intake
timeFrame: 4 months after start of weight loss program
measure: Video Lesson Viewing
timeFrame: 4 months after start of weight loss program
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital's Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital's Weight Control and Diabetes Research Center
name: Jessica L Unick, PhD
role: PRINCIPAL_INVESTIGATOR
References: