Behavioral Therapies for Weight Loss

Overseen By Brie Sullivan

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Fred Hutchinson Cancer Research Center

Disqualifiers: Binge eating, Severe depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 28

Duration: 12 months

418 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase III trial compares telephone delivered Acceptance and Commitment Therapy to standard behavioral therapy for improving weight loss in overweight or obese participants. Acceptance and Commitment Therapy focuses on increasing willingness to experience physical cravings, emotions, and thoughts while making values-guided committed behavior changes. Acceptance and Commitment Therapy may work better at improving weight loss compared to standard behavioral therapy.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have changed the dosage of prescription medications that affect weight or appetite in the past 3 months, you may not be eligible to participate.

What data supports the effectiveness of the treatment Telephone-Based Intervention, Telephone-Based Smoking Cessation Intervention, Phone-Based Smoking Cessation Support for weight loss?

Research shows that phone-based programs are effective for helping people quit smoking, which is a key part of the treatment. Additionally, addressing weight concerns during smoking cessation has been tested, suggesting that combining these approaches could be beneficial. ^{1 2 3 4 5}

Is telephone-based behavioral therapy safe for humans?

Telephone-based behavioral therapies, often used for smoking cessation, are generally considered safe for humans. These programs provide support and counseling over the phone, which is a non-invasive method and does not involve any physical risks. ^{1 2 3 6 7}

How is the Telephone-Based Intervention for weight loss different from other treatments?

The Telephone-Based Intervention for weight loss is unique because it provides support and guidance over the phone, making it more accessible and convenient compared to face-to-face treatments. This approach is particularly effective in promoting healthy behaviors like eating well and staying active, but it is currently under-utilized for weight loss. ^{2 3 5 8 9}

Research Team

Jonathan B Bricker

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

This trial is for US residents who are overweight or obese (BMI >= 27 but <= 45.5), not pregnant, and without certain medical conditions like severe heart disease, uncontrolled hypertension, or cancer. Participants must be willing to try a new weight loss therapy over the phone, have daily access to a phone and email, can read English, aren't on other weight loss programs or studies, and haven't had significant weight changes recently.

Inclusion Criteria

Not participating in or planning to participate in other weight loss programs

For outcome data retention, eligibility criteria included: Willing to complete follow-up surveys, and provide email, phone, and mailing address

I have not lost more than 5% of my weight in the last 6 months.

Exclusion Criteria

I do not meet the specific requirements listed for the trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ACT or SBT telephone coaching over the course of 12 months, with calls 1-16 weekly, calls 17-23 biweekly, and calls 24-25 monthly.

12 months

25 calls (telephone)

Follow-up

Participants are monitored for weight loss, physical activity, and dietary intake at 6, 12, and 24 months post-randomization.

24 months

3 follow-up assessments (remote)

Treatment Details

Interventions

• Telephone-Based Intervention

Trial Overview The study tests if Acceptance and Commitment Therapy delivered by telephone helps with weight loss better than standard behavioral therapy. It involves accepting cravings while making committed changes aligned with personal values. Participants will be randomly assigned to one of these two approaches.

Participant Groups

Group I: Arm I (ACT) Experimental Treatment 2 Interventions

Participants receive ACT telephone coaching over the course of 12 months, calls 1-16 weekly, calls 17-23 biweekly, and calls 24-25 monthly. Call 1 is 30 minutes in duration, while calls 2-25 are each 15-20 minutes in duration.

Group II: Arm II (SBT) Active Control 2 Interventions

Participants receive SBT telephone coaching over the course of 12 months, calls 1-16 weekly, calls 17-23 biweekly, and calls 24-25 monthly. Call 1 is 30 minutes in duration, while calls 2-25 are each 15-20 minutes in duration.

Telephone-Based Intervention is already approved in United States for the following indications:

Approved in United States as Telephone-Based Smoking Cessation Intervention for:

• Smoking cessation in pregnant women
• Prevention of low birth weight

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Research Center

Lead Sponsor

Trials

444

Recruited

148,000+

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

In a study of 837 daily smokers, those receiving telephone care had a significantly higher 6-month smoking cessation rate (13.0%) compared to those receiving standard care (4.1%), indicating that telephone counseling is a more effective intervention.

Participants in the telephone care group were much more likely to engage in counseling programs (97.1% vs 24.0%) and use smoking cessation medications (89.6% vs 52.3%), suggesting that telephone care enhances both behavioral and pharmacological support for quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of telephone care over primary care for smoking cessation: a randomized trial. An, LC., Zhu, SH., Nelson, DB., et al.[2022]

Telephonic tobacco cessation coaching significantly improved quit rates among participants (31%) compared to matched controls (23%), demonstrating its effectiveness in real-world clinical settings.

Participants in the coaching program also filled prescriptions for tobacco cessation medications at a much higher rate (47%) than those who received no treatment (6%), indicating that the coaching not only helped with quitting but also encouraged the use of cessation aids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone-Based Coaching. Boccio, M., Sanna, RS., Adams, SR., et al.[2022]

A telephone-based lifestyle program for weight loss led to a significant average weight loss of 4.25 kg over 12 months among participants, indicating its effectiveness as an alternative to face-to-face obesity treatments.

The program was well-accepted, especially by men, and resulted in additional health benefits such as reduced abdominal girth and lower cholesterol levels, suggesting it can improve overall metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-Year Weight Loss with a Telephone-Based Lifestyle Program. Holzapfel, C., Merl, M., Stecher, L., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Benefits of telephone care over primary care for smoking cessation: a randomized trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Addressing weight gain in smoking cessation treatment: a randomized controlled trial. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Phone and web-based tobacco cessation treatment: real-world utilization patterns and outcomes for 11,000 tobacco users. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of adding weight control simultaneously or sequentially to smoking cessation quitlines: study protocol of a randomized controlled trial. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

Utilization of a Web-based vs integrated phone/Web cessation program among 140,000 tobacco users: an evaluation across 10 free state quitlines. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Telephone-Based Coaching. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Mobile Phone-Based Interventions for Smoking Cessation Among Young People: Systematic Review and Meta-Analysis. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

One-Year Weight Loss with a Telephone-Based Lifestyle Program. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Increasing the use of preventative health services to promote healthy eating, physical activity and weight management: the acceptability and potential effectiveness of a proactive telemarketing approach. [2021]