Phone Coaching and Internet-delivered Weight Loss

NCT03867981 | Completed Results

• 2 other identifiers: 12960205R01DK117843
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; weight loss; exercise; diet; phone coaching

Outcome Measures

Primary Outcomes (2)

• Percent Weight Change at 4 Months

  Weight change was assessed using weight at baseline and 4 months

  4 months after start of weight loss program

• Percent Weight Change at 12 Months

  Weight change was assessed using weight at baseline and 12 months

  12 months after start of weight loss program

Secondary Outcomes (5)

• Cost of Supplemental Coaching Per kg of Weight Loss

  12 months after start of weight loss program

• Change in Physical Activity Minutes (Min/wk)

  4 months after study enrollment

• Change in Dietary Intake (Kcals)

  4 months after start of weight loss program

• Self-monitoring of Calorie Intake

  4 months after start of weight loss program

• Video Lesson Viewing

  4 months after start of weight loss program

Study Arms (3)

Internet weight loss + possibility of brief phone coaching

EXPERIMENTAL

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; Behavioral: Brief phone coaching

Internet weight loss + possibility of extended phone coaching

EXPERIMENTAL

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; Behavioral: Extended phone coaching

Internet weight loss only

ACTIVE COMPARATOR

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

Interventions

Internet-based weight loss program BEHAVIORAL

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

Internet weight loss + possibility of brief phone coaching; Internet weight loss + possibility of extended phone coaching; Internet weight loss only

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.

Internet weight loss + possibility of brief phone coaching

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.

Internet weight loss + possibility of extended phone coaching

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70
• BMI: 25-45 kg/m2
• Regular internet access

You may not qualify if:

• 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

Sponsors & Collaborators

• The Miriam Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

The Miriam Hospital's Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

• Unick JL, Pellegrini CA, Dunsiger SI, Demos KE, Thomas JG, Bond DS, Lee RH, Webster J, Wing RR. An Adaptive Telephone Coaching Intervention for Patients in an Online Weight Loss Program: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2414587. doi: 10.1001/jamanetworkopen.2024.14587.

  PMID: 38848067 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior

Results Point of Contact

• Title: Principal Investigator
• Organization: The Miriam Hospital

junick@lifespan.org

401-793-8966

Study Officials

• Jessica L Unick, PhD

  The Miriam Hospital's Weight Control and Diabetes Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 8, 2019
• Study Start: March 6, 2019
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: July 17, 2024
• Results First Posted: July 17, 2024

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: baseline to 12 months
• Access Criteria: Requests to view or utilize de-identified, participant-level data can be sent to the Principal Investigator (Dr. Jessica Unick - junick@lifespan.org).

Locations

US (1)