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Phone Coaching and Internet-delivered Weight Loss

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ClinicalTrials.gov Identifier: NCT03867981
Recruitment Status : Recruiting
First Posted : March 8, 2019
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Internet-based weight loss program Behavioral: Brief phone coaching Behavioral: Extended phone coaching Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phone Coaching and Internet-delivered Weight Loss
Actual Study Start Date : March 6, 2019
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Percent weight change at 4 months [ Time Frame: 4 months after start of weight loss program ]
  2. Percent weight change at 12 months [ Time Frame: 12 months after start of weight loss program ]

Secondary Outcome Measures :
  1. Cost per kg of weight loss [ Time Frame: 4 months and 12 months after start of weight loss program ]
  2. Change in physical activity minutes (min/wk) [ Time Frame: 4 months after study enrollment ]
  3. Change in dietary intake (kcals) [ Time Frame: 4 months after start of weight loss program ]
  4. Self-monitoring [ Time Frame: 4 months after start of weight loss program ]
    number of days that participant self-monitored on study website

  5. Video lesson viewing [ Time Frame: 4 months after start of weight loss program ]
    number of video lessons viewed on study website



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03867981


Contacts
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Contact: Jennifer Webster 401-793-8946 jwebster@lifespan.org

Locations
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United States, Rhode Island
The Miriam Hospital's Weight Control and Diabetes Research Center Recruiting
Providence, Rhode Island, United States, 02903
Contact: Jessica Unick, PhD    401-793-8966    junick@lifespan.org   
Principal Investigator: Jessica Unick, PhD         
Sponsors and Collaborators
The Miriam Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Jessica L Unick, PhD The Miriam Hospital's Weight Control and Diabetes Research Center
  Study Documents (Full-Text)

Documents provided by The Miriam Hospital:
Informed Consent Form  [PDF] April 1, 2019


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Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT03867981     History of Changes
Other Study ID Numbers: 1296020
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Miriam Hospital:
Obesity
weight loss
exercise
diet
phone coaching
Additional relevant MeSH terms:
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Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes