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Pilot Trial of a Telephone Weight Loss, Nutrition, Exercise Study (WeLNES)

Primary Purpose

Weight Loss, Weight, Body

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TALK study group
TALK control group
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Weight Loss focused on measuring Weight loss, Nutrition, Exercise, Diet, Telephone coaching

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age 18 or older,
  • overweight or obese (BMI ≥ 27),
  • wants to lose weight through healthy behavior change, beginning in the next 30 days,
  • interested in learning skills to lose weight,
  • willing to be randomly assigned to either condition,
  • resides in US,
  • has daily access to their own phone and email,
  • does not have a medical or psychiatric condition that would limit their ability to comply with the behavioral recommendations of the program or pose a risk to the participant during weight loss, including meeting criteria for binge eating disorder,
  • not pregnant or planning to become pregnant in the next 12 months,
  • in the past 3 months changed the dosage of prescription medications that can cause a significant change in weight or appetite,
  • have lost more than 5% of their weight in the past 6 months,
  • willing and able to read in English,
  • not participating in or planning to participate in other weight loss programs, and
  • has not participated in our other ACT interventions. To increase follow-up data retention, eligibility criteria also include:
  • willing to complete the follow-up survey, and (16) provide email, phone, and mailing address.

Exclusion Criteria:

  • Opposite of the inclusion criteria

Sites / Locations

  • Fred Hutchinson Cancer Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control

Arm Description

This is the experimental arm of the study. This includes 25 weekly then biweekly sessions of experimental therapy via telephone. Therapy description withheld to protect the integrity of the study.

This is the control arm of the study. This includes This includes 25 weekly then biweekly sessions of control therapy via telephone.Therapy description withheld to protect the integrity of the study.

Outcomes

Primary Outcome Measures

12-month weight loss
Weight loss measured by BodyTrace scale. The BodyTrace medical body weight scale is a physical scale capable of assessing weight from 0.2 lbs to 397 lbs (0.1 kg to 180 kg) and securely sending data remotely through cellular (GSM) network.

Secondary Outcome Measures

3-month weight loss
Weight loss measured by BodyTrace scale. The BodyTrace medical body weight scale is a physical scale capable of assessing weight from 0.2 lbs to 397 lbs (0.1 kg to 180 kg) and securely sending data remotely through cellular (GSM) network.
6-month weight loss
Weight loss measured by BodyTrace scale. The BodyTrace medical body weight scale is a physical scale capable of assessing weight from 0.2 lbs to 397 lbs (0.1 kg to 180 kg) and securely sending data remotely through cellular (GSM) network.

Full Information

First Posted
October 2, 2018
Last Updated
January 5, 2021
Sponsor
Fred Hutchinson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03738540
Brief Title
Pilot Trial of a Telephone Weight Loss, Nutrition, Exercise Study
Acronym
WeLNES
Official Title
Pilot Randomized Trial of a Telephone Weight Loss, Nutrition, Exercise Study (WeLNES)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 29, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Many behavioral weight loss interventions have been developed, but still have significant limitations in terms of achieving clinically significant, sustained weight loss. A recent study incorporating Acceptance and Commitment Therapy (ACT) in a randomized clinical trial resulted in participants who attained significantly greater 12-month weight loss in the ACT arm than those assigned to standard behavioral treatment, suggesting that ACT may have the potential to improve behavioral weight loss outcomes. The investigators have developed a novel telephone-delivered version of the ACT behavioral weight loss intervention, based on proven success using ACT telephone counseling intervention for smoking cessation.
Detailed Description
There is consistent evidence from observational studies that higher amounts of body fat are associated with increased risks of cancer. Many behavioral weight loss interventions have been developed, but still have significant limitations in terms of achieving clinically significant, sustained weight loss. A recent study incorporating Acceptance and Commitment Therapy (ACT) in a randomized clinical trial resulted in participants who attained significantly greater 12-month weight loss in the ACT arm than those assigned to standard behavioral treatment, suggesting that ACT may have the potential to improve behavioral weight loss outcomes. However, this study required in-person clinic visits with treatment groups, which limits its potential reach and disseminability. The investigators have developed a novel telephone-delivered version of the ACT behavioral weight loss intervention, based on our proven success using ACT telephone counseling intervention for smoking cessation. There will be a two-arm pilot randomized trial (N = 100), comparing the ACT telephone intervention to a standard behavioral treatment (SBT) telephone control. The pilot RCT will yield engagement, receptivity, and preliminary weight loss results that will provide critical and timely weight loss intervention data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Weight, Body
Keywords
Weight loss, Nutrition, Exercise, Diet, Telephone coaching

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
This is the experimental arm of the study. This includes 25 weekly then biweekly sessions of experimental therapy via telephone. Therapy description withheld to protect the integrity of the study.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
This is the control arm of the study. This includes This includes 25 weekly then biweekly sessions of control therapy via telephone.Therapy description withheld to protect the integrity of the study.
Intervention Type
Behavioral
Intervention Name(s)
TALK study group
Intervention Description
Telephone Delivered Intervention
Intervention Type
Behavioral
Intervention Name(s)
TALK control group
Intervention Description
Telephone Delivered Intervention
Primary Outcome Measure Information:
Title
12-month weight loss
Description
Weight loss measured by BodyTrace scale. The BodyTrace medical body weight scale is a physical scale capable of assessing weight from 0.2 lbs to 397 lbs (0.1 kg to 180 kg) and securely sending data remotely through cellular (GSM) network.
Time Frame
12 months post randomization
Secondary Outcome Measure Information:
Title
3-month weight loss
Description
Weight loss measured by BodyTrace scale. The BodyTrace medical body weight scale is a physical scale capable of assessing weight from 0.2 lbs to 397 lbs (0.1 kg to 180 kg) and securely sending data remotely through cellular (GSM) network.
Time Frame
3 months post randomization
Title
6-month weight loss
Description
Weight loss measured by BodyTrace scale. The BodyTrace medical body weight scale is a physical scale capable of assessing weight from 0.2 lbs to 397 lbs (0.1 kg to 180 kg) and securely sending data remotely through cellular (GSM) network.
Time Frame
6 months post randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age 18 or older, overweight or obese (BMI ≥ 27), wants to lose weight through healthy behavior change, beginning in the next 30 days, interested in learning skills to lose weight, willing to be randomly assigned to either condition, resides in US, has daily access to their own phone and email, does not have a medical or psychiatric condition that would limit their ability to comply with the behavioral recommendations of the program or pose a risk to the participant during weight loss, including meeting criteria for binge eating disorder, not pregnant or planning to become pregnant in the next 12 months, in the past 3 months changed the dosage of prescription medications that can cause a significant change in weight or appetite, have lost more than 5% of their weight in the past 6 months, willing and able to read in English, not participating in or planning to participate in other weight loss programs, and has not participated in our other ACT interventions. To increase follow-up data retention, eligibility criteria also include: willing to complete the follow-up survey, and (16) provide email, phone, and mailing address. Exclusion Criteria: Opposite of the inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Bricker, PhD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33787926
Citation
Bricker JB, Mull KE, Sullivan BM, Forman EM. Efficacy of telehealth acceptance and commitment therapy for weight loss: a pilot randomized clinical trial. Transl Behav Med. 2021 Aug 13;11(8):1527-1536. doi: 10.1093/tbm/ibab012.
Results Reference
derived
Links:
URL
http://welnes.org
Description
Study recruitment website

Learn more about this trial

Pilot Trial of a Telephone Weight Loss, Nutrition, Exercise Study

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