Lifestyle Intervention for Obesity

Overseen By Francesca Gany, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: GLP-1 agonists, Phentermine, Orlistat

Disqualifiers: Pregnancy, Cancer, Kidney disease, others

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

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

Compensation: Varies

Number of Visits: 1

Duration: 12 months

1067 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a program called 'Taxi ROADmAP' to help taxi and for-hire vehicle drivers improve their diet and physical activity to lose weight. The program targets drivers who are often from low-income backgrounds and have higher obesity rates. It uses behavior change techniques to find the best ways to help these drivers adopt healthier habits.

Will I have to stop taking my current medications?

If you are currently taking medications specifically for obesity, like Ozempic, Wegovy, or similar drugs, you will need to stop taking them at least 7 weeks before joining the trial. For other medications, the trial protocol does not specify any requirements to stop them.

What data supports the effectiveness of this treatment for obesity?

Research shows that telephone and text message support can effectively help people stick to lifestyle changes and improve health outcomes in obesity management. Additionally, using smartphone apps for dietary guidance has been shown to improve diet quality over time. ^{1 2 3 4 5}

Is lifestyle intervention for obesity safe for humans?

Research shows that lifestyle interventions like phone calls, text messages, and counseling for diet and exercise are generally safe for humans. These methods are used to support healthy behavior changes and have been found feasible and effective in managing obesity. ^{3 5 6 7 8}

How is the Lifestyle Intervention for Obesity treatment different from other treatments?

This treatment is unique because it combines counseling, phone calls, self-monitoring tools, and text messages to support lifestyle changes, making it more accessible and personalized compared to traditional in-person methods. It leverages technology to provide ongoing support and motivation, which can enhance adherence and effectiveness in managing obesity. ^{3 4 5 9 10}

Research Team

Jennifer Leng, MD, MPH

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

The Taxi ROADmAP trial is for full-time taxi and FHV drivers in NYC who are at least 21 years old, have been driving for over 6 months, speak English/French/Bengali/Spanish, own a cell phone that can get texts, and are overweight or obese. It's not for those pregnant or with chronic diseases like cancer.

Inclusion Criteria

For SANOS focus group participants only: Agrees to be audio recorded

I am overweight or obese based on my BMI.

I am at least 21 years old.

Exclusion Criteria

For SANOS focus group participants only: Lactating women

For SANOS focus group participants only: Has a household member who has already participated (or agreed to participate)

For ROADmAP RCT participants only: Currently has dietary restrictions (i.e. liquid diet)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive one or a combination of 4 conditions: in-person individualized diet and exercise counseling, diet and exercise text messages, weekly telephone support, and self-monitoring tools for diet and weight

12 months

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including weight loss and cost-effectiveness assessments

6 months

Follow-up surveys and data collection

Treatment Details

Interventions

• Counseling
• Phone calls
• Self-monitoring tools
• Text Messages

Trial Overview This study tests a lifestyle intervention to help taxi/FHV drivers lose weight using text messages, self-monitoring tools, phone calls, and counseling based on Social Cognitive Theory. The effectiveness-implementation hybrid design aims to optimize diet and physical activity.

Participant Groups

Group I: SANOS Experimental Treatment 1 Intervention

Conducting SANOS Focus Groups. We will conduct 3-5 focus groups (in Spanish) with 6-10 participants each, until saturation. Bilingual study staff will approach individuals visiting the VDS and VDS Mobile for potential participation. A brief screening questionnaire will be administered, and a BMI assessment conducted, to ascertain eligibility. Focus groups will be scheduled at the VDS Mobile unit at times convenient to participants. Participants will be verbally consented in Spanish, and will be apprised that their participation is purely voluntary and that their names will not be included in the final narrative. The 6-month follow-up and my plate dietary surveys can be done over phone. Study staff will access step counts (or obtain it through phone via the pedometer manual provided to the participant) and upload data onto the REDCap tracking tool. Staff may ask participants to report step counts captured by their personal devices (i.e., phone or smartwatch).

Group II: ROADmAP schema Experimental Treatment 4 Interventions

Participants will be randomly assigned to one of eight study groups which will be one or a combination of 4 conditions: (1) in person individualized diet and exercise counseling (2) diet and exercise text messages (3) weekly telephone support and (4) self-monitoring tools for diet and weight. For the first part of the study, Survey, approximately 64 drivers and 36 management staff will take pate in the feedback questionnaire. For the second part of the study, Interview, approximately 8 drivers and 12 management staff may be invited to take part in an interview via phone, in person, or teleconference (Zoom).

Group III: Consumo de Opciones Mas Ideales De Alimento (COMIDA) Experimental Treatment 1 Intervention

Participants will be placed in either individual or group interventions by convenience. Recruitment will be consecutive and participants will be placed in either intervention depending on what resource is available on a given day at the VDS, individual counselor or a group educator.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

A study involving 55 patients with obesity found that dietary education provided in a grocery store setting led to greater increases in nutritional knowledge compared to traditional clinic-based advice, with grocery participants improving by an average of 5.7 points versus 3.2 points for clinic participants.

Both groups showed improvements in dietary quality, suggesting that grocery store-based dietary counselling is a feasible and effective alternative for enhancing nutritional education and engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The personal shopper--a pilot randomized trial of grocery store-based dietary advice. Lewis, KH., Roblin, DW., Leo, M., et al.[2018]

In a study of 10,870 adults with diabetes, higher intensity and heterogeneity in lifestyle counseling documentation were linked to improved glycemic control, with patients in the highest tertile achieving HbA1c levels below 7.0% faster than those in the lowest tertile.

Specifically, an increase in documentation intensity by 45 characters per note and heterogeneity by 0.15 units significantly correlated with quicker time to reach target HbA1c levels, suggesting that detailed and varied counseling notes can enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic Documentation of Lifestyle Counseling and Glycemic Control in Patients With Diabetes. Hosomura, N., Goldberg, SI., Shubina, M., et al.[2022]

A systematic review of 26 studies found that telephone counseling interventions for physical activity and dietary behavior change are effective, with 20 out of 26 studies reporting significant improvements in behavior.

Interventions lasting 6 to 12 months and involving 12 or more calls were associated with the most favorable outcomes, highlighting the importance of duration and frequency in achieving positive behavior changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone interventions for physical activity and dietary behavior change: a systematic review. Eakin, EG., Lawler, SP., Vandelanotte, C., et al.[2022]

A study involving 833 participants showed that adding a diet smartphone application to standard counseling significantly improved dietary composition over 12 months, with the intervention group (IG) reporting better changes than the control group (CG).

The IG had a higher percentage intake of carbohydrates and lower intakes of fats and saturated fats compared to the CG, indicating that the app helped participants modify their diets more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of a Smartphone Application on Modifying the Intakes of Macro and Micronutrients in Primary Care: A Randomized Controlled Trial. The EVIDENT II Study. Recio-Rodriguez, JI., Agudo Conde, C., Calvo-Aponte, MJ., et al.[2019]

Participants in a telehealth trial for obesity management reported that telephone and text message support were highly beneficial, providing motivation and accountability.

The study indicates strong acceptability of these communication methods, suggesting they could be effectively integrated into community-based obesity management programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participant perspectives of a telehealth trial investigating the use of telephone and text message support in obesity management: a qualitative evaluation. Lewis, E., Hassmén, P., Pumpa, KL.[2021]

The digitally delivered behavioral counseling program effectively engaged employees, with 83% completing most of the curriculum and 31% achieving a weight loss of at least 5%.

Participants in the program showed significant improvements in weight, fasting blood glucose levels, and nutritional intake compared to a matched group of non-participants after one year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Digital Behavioral Counseling Program for Reducing Risk Factors for Chronic Disease in a Workforce. Wilson, MG., Castro Sweet, CM., Edge, MD., et al.[2023]

Effective management of obesity requires a combination of diet, exercise, behavioral support, and sometimes medication, highlighting the importance of a comprehensive approach to weight management.

Behavioral counseling techniques, such as self-monitoring and social support, are crucial for overcoming barriers to compliance and enhancing motivation for physical activity, which is essential for successful weight loss and maintenance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State of the science: a focus on physical activity. Hills, AP., Byrne, NM.[2006]

A pilot study involving 50 obese black women tested a 6-month text messaging intervention for weight loss, showing that participants in the intervention group lost an average of 1.27 kg, while the control group gained weight, indicating potential efficacy of the text messaging approach.

The study found that 85% of participants engaged with the self-monitoring prompts at least twice a week, and many reported that the daily texting was easy and helpful, suggesting that text messaging could be a feasible tool for weight management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily text messaging for weight control among racial and ethnic minority women: randomized controlled pilot study. Steinberg, DM., Levine, EL., Askew, S., et al.[2021]

An online lifestyle intervention coaching protocol was developed based on the Diabetes Prevention Program, aiming to provide effective obesity treatment in primary care settings.

This e-counseling approach allows for high-quality lifestyle advice to be accessible to patients who cannot attend in-person sessions due to scheduling or geographic limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an online diabetes prevention lifestyle intervention coaching protocol for use in primary care practice. Simkin-Silverman, LR., Conroy, MB., Bhargava, T., et al.[2018]

Over 60% of US adults are overweight or obese, which increases their risk for chronic diseases like cardiovascular disease, highlighting the urgent need for effective weight management strategies.

Even small changes in physical activity and diet can lead to significant weight loss and help maintain a healthy body composition, yet many patients do not receive adequate guidance from healthcare providers on how to achieve these changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet, exercise, and the challenge of combating obesity in primary care. McInnis, KJ.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

The personal shopper--a pilot randomized trial of grocery store-based dietary advice. [2018]

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

Electronic Documentation of Lifestyle Counseling and Glycemic Control in Patients With Diabetes. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Telephone interventions for physical activity and dietary behavior change: a systematic review. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Effectiveness of a Smartphone Application on Modifying the Intakes of Macro and Micronutrients in Primary Care: A Randomized Controlled Trial. The EVIDENT II Study. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Participant perspectives of a telehealth trial investigating the use of telephone and text message support in obesity management: a qualitative evaluation. [2021]

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

Evaluation of a Digital Behavioral Counseling Program for Reducing Risk Factors for Chronic Disease in a Workforce. [2023]

7. China pubmed.ncbi.nlm.nih.gov

State of the science: a focus on physical activity. [2006]

8. Canada pubmed.ncbi.nlm.nih.gov

Daily text messaging for weight control among racial and ethnic minority women: randomized controlled pilot study. [2021]

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

Development of an online diabetes prevention lifestyle intervention coaching protocol for use in primary care practice. [2018]

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

Diet, exercise, and the challenge of combating obesity in primary care. [2019]