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

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

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss; Weight, Body
• Intervention / Treatment: Behavioral: TALK study group; Behavioral: TALK control group

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; 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.	Behavioral: TALK study group; Telephone Delivered Intervention
Active Comparator: Control; 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.	Behavioral: TALK control group; Telephone Delivered Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months post randomization
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.	6 months post randomization

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Investigators: Principal Investigator: Jonathan Bricker, PhD, Fred Hutchinson Cancer Center

Publications and helpful links

General Publications

• 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.

Helpful Links

• Study recruitment website

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2018
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: November 8, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): January 7, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Exercise; Nutrition; Weight loss; Diet; Telephone coaching
• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: 8693; NCI-2019-02521 (Registry Identifier: NCI / CTRP); RG1001915 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No