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Completed

NCT Number: NCT03867981

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.

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Key information

Conditions

Obesity Behavior Body Weight Body Weight Changes Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Miriam Hospital's Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-based weight loss program

Behavioral

12-month, Internet-based weight loss/maintenance program.

Brief phone coaching

Behavioral

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.

Extended phone coaching

Behavioral

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 outcomes

  1. Percent Weight Change at 4 Months

    Time frame: 4 months after start of weight loss program

    Weight change was assessed using weight at baseline and 4 months

  2. Percent Weight Change at 12 Months

    Time frame: 12 months after start of weight loss program

    Weight change was assessed using weight at baseline and 12 months

Secondary outcomes

  1. Cost of Supplemental Coaching Per kg of Weight Loss

    Time frame: 12 months after start of weight loss program

    Cost-effectiveness analyses were completed to determine the intervention cost per kg of weight loss

  2. Change in Physical Activity Minutes (Min/wk)

    Time frame: 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.

  3. Change in Dietary Intake (Kcals)

    Time frame: 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.

  4. Self-monitoring of Calorie Intake

    Time frame: 4 months after start of weight loss program

    Percentage of days that participant self-monitored their calorie intake on study website

  5. Video Lesson Viewing

    Time frame: 4 months after start of weight loss program

    Percentage of video lessons viewed on study website

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 8, 2019
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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