Sugary Drink Ban + Counseling for Metabolic Health Improvement

(MHIP Trial)

Overseen By Sweet Study Contact

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Pregnant

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

700 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to test the impact of a multilevel workplace intervention (hospital-wide sales ban on sugar-sweetened beverages (SSBs) and individual-level brief counseling) on employee health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Sugary Drink Ban + Counseling for Metabolic Health Improvement?

Research shows that counseling, especially when delivered through motivational interviewing and brief interventions, can lead to positive changes in dietary habits and metabolic health. For example, studies have found that telephone-delivered nutrition education and motivational interviewing can significantly reduce weight, body fat, and improve dietary behaviors, which are important for managing metabolic syndrome. ^{1 2 3 4 5}

Is the Sugary Drink Ban + Counseling treatment safe for humans?

Research on motivational interviewing, a key part of this treatment, shows it is generally safe and has been used to help improve diet and weight management in various groups, including women with type 2 diabetes and caregivers for obesity prevention. ^{3 6 7 8 9}

How is the Sugary Drink Ban + Counseling treatment different from other treatments for metabolic health improvement?

This treatment is unique because it combines a ban on sugary drinks with brief counseling using motivational interviewing, which helps patients set and achieve realistic lifestyle goals. Unlike other treatments that may focus solely on diet or medication, this approach emphasizes behavior change and self-management to improve metabolic health. ^{3 10 11 12 13}

Research Team

Laura A Schmidt, Ph.D

Principal Investigator

University of California, San Francisco

Elissa Epel, Ph.D

Principal Investigator

University of California, San Francisco

Jamey Schmidt

Principal Investigator

Sutter Health/California Pacific Medical Center Research Institute

Eligibility Criteria

This trial is for full-time employees at certain Sutter Health sites who drink three or more sugary drinks a week, can speak and read English, and are willing to have two fasting blood tests. Pregnant individuals cannot participate.

Inclusion Criteria

Full-time employee who works on campus at one of the Sutter Health participating sites

You drink three or more sugary drinks every week.

Speaks and reads English

Exclusion Criteria

Pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a workplace SSB sales ban and/or brief counseling intervention

12 months

1 initial video call, 2 booster phone calls

Follow-up

Participants are monitored for changes in health metrics such as lipid profile, insulin sensitivity, and BMI

12 months

Treatment Details

Interventions

• Brief Intervention
• Workplace SSB sales ban

Trial Overview The study examines the effects of not selling sugary drinks (SSBs) at work and giving motivational counseling on employee health, specifically focusing on insulin resistance and abdominal obesity.

Participant Groups

Group I: Workplace SSB sales ban only Experimental Treatment 1 Intervention

Participants receive a workplace SSB sales ban (environmental intervention). This entails the removal of SSBs from all workplace sales outlets, replacing them with non-sugary beverage options.

Group II: Multilevel Intervention (workplace SSB sales ban + brief intervention) Experimental Treatment 2 Interventions

Sales ban: Participants receive a workplace SSB sales ban (environmental intervention). This entails the removal of SSBs from all workplace sales outlets, replacing them with non-sugary beverage options. Brief Intervention: Participants receive a 20-30 minute intervention by video call, with 2 booster telephone calls. One week and one month after the initial session, participants will have 10-minute check-in/booster phone calls.

Group III: Brief intervention only Experimental Treatment 1 Intervention

Participants receive a 20-30 minute intervention by video call, with 2 booster telephone calls. One week and one month after the initial session, participants will have 10-minute check-in/booster phone calls.

Group IV: Control: No workplace SSB sales ban, no brief intervention Active Control 1 Intervention

Participants receive no workplace SSB sales ban (environmental intervention) and no brief counseling intervention.

Brief Intervention is already approved in United States, European Union for the following indications:

Approved in United States as Brief Intervention for:

• Alcohol misuse in HIV care
• Substance use disorder

Approved in European Union as Brief Intervention for:

• Alcohol misuse
• Substance use disorder

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Sutter Health

Collaborator

Trials

26

Recruited

68,900+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

California Pacific Medical Center Research Institute

Collaborator

Trials

44

Recruited

10,600+

Findings from Research

A study involving 71 adults with metabolic syndrome found that those receiving in-depth telephone-delivered nutrition education had significantly greater reductions in weight, body fat, and abdominal circumference compared to those who had a single visit with a dietitian.

After 3 months, the prevalence of metabolic syndrome decreased to 45.5% in the telephone counseling group, compared to 69.7% in the single-visit group, highlighting the effectiveness of ongoing dietary support through phone counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the telephone-delivered nutrition education on dietary intake and biochemical parameters in subjects with metabolic syndrome. Kim, J., Bea, W., Lee, K., et al.[2021]

In a study involving 151 adults with type 2 diabetes, participants who completed more telephone counseling calls (up to 27 over 18 months) experienced a significant weight loss of -3.3% compared to those with low call completion.

While increased call completion was linked to greater weight loss, it did not show significant effects on other outcomes like physical activity or diet quality, highlighting the need for strategies to keep patients engaged in weight loss interventions, especially those with comorbid depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between intervention dose and outcomes in living well with diabetes--a randomized trial of a telephone-delivered lifestyle-based weight loss intervention. Goode, AD., Winkler, EA., Reeves, MM., et al.[2022]

Dietitians who received basic training in motivational interviewing (MI) showed significant improvements in their counseling style, becoming more empathetic and allowing patients to speak more during consultations.

Patients of MI-trained dietitians reported lower saturated fat intake, indicating that the training effectively influenced dietary habits, although there were no significant changes in other health parameters like HbA1c, BMI, or waist circumference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training dietitians in basic motivational interviewing skills results in changes in their counseling style and in lower saturated fat intakes in their patients. Brug, J., Spikmans, F., Aartsen, C., et al.[2007]

Training healthcare providers in brief motivational interviewing (MI) significantly improved their knowledge and confidence in counseling patients about eating and exercise behaviors, with these improvements lasting for at least 6 months after training.

The study involved 163 healthcare providers, with 128 receiving a one-day training workshop, and showed that brief MI skills can be effectively taught and applied as an intervention for obesity prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building skills, knowledge and confidence in eating and exercise behavior change: brief motivational interviewing training for healthcare providers. Edwards, EJ., Stapleton, P., Williams, K., et al.[2016]

A personalized, medical office-based intervention for dietary self-management in 206 adults with diabetes led to significant improvements in dietary behavior and serum cholesterol levels after 12 months, compared to usual care.

The intervention was cost-effective at $137 per patient and resulted in higher patient satisfaction, although it did not significantly affect HbA1c levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects and costs of brief behavioural dietary intervention for patients with diabetes delivered from the medical office. Glasgow, RE., La Chance, PA., Toobert, DJ., et al.[2019]

The study involving 36 parent and adult caregiver-child dyads showed that motivational interviewing (MI) by registered dietitians can lead to improvements in the dietary quality of caregivers, as indicated by increased Healthy Eating Index (HEI) scores.

Improvements in the home food environment were also observed, suggesting that MI not only benefits the caregivers' diets but may also positively influence children's dietary habits and the overall home setting for healthier eating.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Support for the Use of Motivational Interviewing to Improve Parent/Adult Caregiver Behavior for Obesity and Cancer Prevention. Braun, A., Portner, J., Xu, M., et al.[2023]

A nonrandomized clinical trial involving 91 children aged 3 to 7 showed that motivational interviewing by pediatricians and dietitians can lead to a decrease in body mass index percentiles, with the intensive intervention group experiencing the greatest reduction (2.6 percentiles).

Despite the positive feedback from parents about the intervention's impact on their family's eating habits, the differences in BMI changes between the intervention groups were not statistically significant, indicating that further research is needed to confirm the effectiveness of this approach in preventing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Office-based motivational interviewing to prevent childhood obesity: a feasibility study. Schwartz, RP., Hamre, R., Dietz, WH., et al.[2007]

Adding motivational interviewing to a behavioral weight control program significantly improved weight loss outcomes for overweight women with type 2 diabetes, with notable weight loss at both 6 months and 18 months.

Participants receiving motivational interviewing also showed greater reductions in A1C levels at 6 months, indicating improved glycemic control, although these benefits were not sustained at 18 months and were less pronounced in African-American women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing improves weight loss in women with type 2 diabetes. West, DS., DiLillo, V., Bursac, Z., et al.[2022]

Motivational interviewing (MI) significantly improved dietary habits in 327 obese/overweight women, leading to increased intake of fiber, whole grains, fruits, and vegetables, while reducing consumption of unhealthy fats and carbohydrates.

The MI intervention resulted in a significant reduction in body weight and BMI over one year, suggesting it is an effective long-term strategy for lifestyle change in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effect of motivational interviewing on dietary intake and weight loss in Iranian obese/overweight women. Saffari, M., Pakpour, AH., Mohammadi-Zeidi, I., et al.[2020]

Obesity is a significant public health issue in America, with 37.9% of adults and 20% of minors classified as obese, leading to substantial medical costs estimated at $147 billion annually.

Sugar-sweetened beverages (SSBs) are identified as a major contributor to obesity, and effective interventions similar to those used in tobacco control—such as labeling, taxation, and marketing restrictions—are proposed to combat this public health crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tackling Obesity and Disease: The Culprit Is Sugar; the Response Is Legal Regulation. Gostin, LO.[2019]

Nutrition therapy for metabolic syndrome focuses on weight management, physical activity, and the consumption of whole grains and fiber, which can help reduce the risk of diabetes and cardiovascular disease.

Dietitians play a crucial role in guiding individuals with metabolic syndrome to implement lifestyle changes that address dietary factors, including the type and amount of fats and carbohydrates, although some aspects, like carbohydrate and alcohol intake, remain debated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of nutrition therapy and dietitians in the management of the metabolic syndrome. Franz, MJ.[2022]

The study evaluates a brief psychological intervention designed to help individuals with Type 2 diabetes make effective lifestyle changes, using motivational interviewing to set realistic goals.

This randomized controlled trial aims to integrate the intervention into routine care, addressing maintenance through follow-up contacts, highlighting the importance of ongoing support in lifestyle management for diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a psychological intervention to improve lifestyle self-management in patients with type 2 diabetes. Clark, M., Hampson, SE.[2019]

Motivational interviewing (MI) in lifestyle discussions with primary health care patients can enhance self-determination and promote positive lifestyle changes, especially when there is mutual interaction and support between the patient and nurse.

Patients who feel motivated and aware of their role in making lifestyle changes find MI strategies beneficial, but the effectiveness of these discussions may vary for less motivated individuals or when different methods are used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' experiences of lifestyle discussions based on motivational interviewing: a qualitative study. Brobeck, E., Odencrants, S., Bergh, H., et al.[2021]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect of the telephone-delivered nutrition education on dietary intake and biochemical parameters in subjects with metabolic syndrome. [2021]

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

Relationship between intervention dose and outcomes in living well with diabetes--a randomized trial of a telephone-delivered lifestyle-based weight loss intervention. [2022]

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

Training dietitians in basic motivational interviewing skills results in changes in their counseling style and in lower saturated fat intakes in their patients. [2007]

4. Ireland pubmed.ncbi.nlm.nih.gov

Building skills, knowledge and confidence in eating and exercise behavior change: brief motivational interviewing training for healthcare providers. [2016]

5. Ireland pubmed.ncbi.nlm.nih.gov

Long-term effects and costs of brief behavioural dietary intervention for patients with diabetes delivered from the medical office. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Preliminary Support for the Use of Motivational Interviewing to Improve Parent/Adult Caregiver Behavior for Obesity and Cancer Prevention. [2023]

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

Office-based motivational interviewing to prevent childhood obesity: a feasibility study. [2007]

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

Motivational interviewing improves weight loss in women with type 2 diabetes. [2022]

9. Iran pubmed.ncbi.nlm.nih.gov

Long-term effect of motivational interviewing on dietary intake and weight loss in Iranian obese/overweight women. [2020]

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

Tackling Obesity and Disease: The Culprit Is Sugar; the Response Is Legal Regulation. [2019]

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

The role of nutrition therapy and dietitians in the management of the metabolic syndrome. [2022]

12. Ireland pubmed.ncbi.nlm.nih.gov

Implementing a psychological intervention to improve lifestyle self-management in patients with type 2 diabetes. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Patients' experiences of lifestyle discussions based on motivational interviewing: a qualitative study. [2021]