'Ai Pono for Obesity

Recruiting at 1 trial location

Overseen By Ki'i Aweau

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Hawaii

Disqualifiers: Cancer, Chronic pain, Pregnancy, others

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

Compensation: Varies

Number of Visits: 36

1780 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Native Hawaiians improve their health by embracing traditional diets and lifestyles. Researchers seek to determine if a program called 'Ai Pono, which focuses on traditional dietary practices, can reduce the risk of diet-related diseases such as diabetes and heart issues. Participants will join a community effort to learn and practice healthier eating and living habits. The trial seeks Native Hawaiian residents who are overweight or have been diagnosed with conditions like type 2 diabetes or high blood pressure. As an unphased trial, this study offers a unique opportunity for participants to contribute to culturally relevant health solutions.

Do I need to stop my current medications for the trial?

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

What prior data suggests that this intervention is safe?

Research shows that 'Ai Pono is being tested for its safety, particularly in addressing obesity and related health issues. Previous studies on treatments using traditional Native Hawaiian diets have demonstrated health improvements without major side effects. Although 'Ai Pono remains under study, these findings suggest it might be well-tolerated.

Since 'Ai Pono involves a change in lifestyle and diet rather than a new drug or surgical procedure, the risk of side effects is generally lower. Participants are less likely to experience negative side effects compared to more intense medical treatments. However, as with any change, individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

'Ai Pono is unique because it takes a community-driven approach to tackle obesity, which is a departure from the typical individual-focused treatments like diet plans, exercise regimens, or medication. This intervention is designed to operate at the community level, allowing entire communities to participate and benefit collectively. Researchers are excited about 'Ai Pono because it aligns with the broader goals of community health and empowerment, potentially offering sustainable lifestyle changes that could lead to long-term health improvements. By engaging the community as a whole, 'Ai Pono aims to create an environment that supports healthy living, which could enhance its effectiveness compared to traditional, individually-targeted methods.

What evidence suggests that 'Ai Pono is effective for improving cardiometabolic health?

Studies have shown that the 'Ai Pono program, which includes digital lifestyle coaching, can help people lose weight. In a trial with 340 participants, individuals lost an average of 4.5 kg (about 10 pounds) over 12 months. The program also aims to improve diet quality and important health measures related to heart and metabolism. Another study highlighted the benefits of using digital tools to enhance eating habits and self-control. These findings suggest that 'Ai Pono, set to be implemented in all 7 communities as part of this trial, may effectively support weight management and overall health. ^{2 6 7 8 9}

Who Is on the Research Team?

Claire Ing, DrPH

Principal Investigator

Principal Investigator

Kulani DeSimone, B.S.

Principal Investigator

Graduate Assistant

Are You a Good Fit for This Trial?

This trial is for Native Hawaiian adults who are overweight or obese, can do moderate exercise like brisk walking for 150 minutes a week, and have type 2 diabetes, pre-diabetes, high blood pressure, or dyslipidemia. They must be willing to participate fully in the program and live in a participating homestead.

Inclusion Criteria

I live in a participating Hawaiian homestead.

My BMI is 25 or higher, indicating I am overweight or obese.

I can do activities like brisk walking for 150 minutes weekly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Quarterly cooking demonstrations and cultural lessons aimed at improving diet quality and social cohesion

5 years

36 events over 5 years

Follow-up

Participants are monitored for changes in diet self-efficacy, social support, and other health markers

4 years

What Are the Treatments Tested in This Trial?

Interventions

• 'Ai Pono

Trial Overview 'Ai Pono involves community-wide cooking demonstrations aimed at promoting traditional Native Hawaiian diets to improve diet quality and cardiometabolic health markers while also enhancing social cohesion among participants.

How Is the Trial Designed?

Group I: Aim 3: Community Level Intervention Experimental Treatment 1 Intervention

Aim 3 is community-driven, supports the overall goal of the PILI 'Āina project, allows all members of the community to benefit, and is strongly promoted within the community. The investigators will design and implement 'Ai Pono, a community-level component that can operate in tandem with PILI 'Āina. This component will not be tested in the group-randomized trial. Instead, all 7 communities will implement 'Ai Pono for the full study period.

Who Is Running the Clinical Trial?

University of Hawaii

Lead Sponsor

Trials

122

Recruited

55,200+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

A randomized controlled trial involving 340 participants showed that a digital lifestyle coaching program led to a significant weight loss of 4.5 kg over 12 months compared to only 1.5 kg in the usual care group, indicating the efficacy of digital coaching for obesity management.

Both groups experienced reductions in hemoglobin A1c levels, suggesting improvements in blood sugar control, but there was no significant difference between the groups, highlighting that while weight loss was greater in the intervention group, blood sugar improvements were similar for both.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Weight Loss in a Primary Care-Anchored eHealth Lifestyle Coaching Program: Randomized Controlled Trial. Hesseldal, L., Christensen, JR., Olesen, TB., et al.[2022]

A new study will evaluate whether a 12-month weight loss program using reinforcement learning (AI) can achieve similar weight loss results as traditional behavioral weight loss methods, but at a lower cost, involving 336 adults with overweight or obesity.

Preliminary results showed that participants using the AI system needed significantly less coaching while achieving nearly the same weight loss as those in the standard program, suggesting that AI could make weight loss support more accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using artificial intelligence to optimize delivery of weight loss treatment: Protocol for an efficacy and cost-effectiveness trial. Forman, EM., Berry, MP., Butryn, ML., et al.[2023]

New generation anti-obesity medications, such as orlistat, phentermine/topiramate, and liraglutide 3.0 mg, have varying safety profiles, with some presenting significant risks like fetal toxicity and gallstone disease, while others mainly cause transient tolerability issues.

Despite their effectiveness in weight loss, the prescription rates for these medications are low, partly due to safety concerns and the need for more long-term data to better understand their risk-benefit profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of new-generation anti-obesity medications: a narrative review. Patel, DK., Stanford, FC.[2023]

A total of 25 anti-obesity medications were withdrawn between 1964 and 2009, primarily due to adverse reactions related to their effects on monoamine neurotransmitters, with 80% of withdrawals supported by case reports.

The most common reasons for withdrawal included psychiatric disturbances, cardiotoxicity, and drug dependence, raising concerns about the safety of using medications that target neurotransmitters for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-marketing withdrawal of anti-obesity medicinal products because of adverse drug reactions: a systematic review. Onakpoya, IJ., Heneghan, CJ., Aronson, JK.[2022]

A study involving 22 participants from a weight management clinic in Singapore identified key features that weight loss apps should include for a multi-ethnic population with overweight and obesity, such as comprehensive calorie counters and individualized behavior change recommendations.

Participants emphasized the importance of flexibility in food logging and the need for apps to provide just-in-time reminders about the consequences of their choices, suggesting that future apps could benefit from artificial intelligence to offer personalized support for weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Essential elements of weight loss apps for a multi-ethnic population with high BMI: a qualitative study with practical recommendations. Chew, HSJ., Lim, SL., Kim, G., et al.[2023]

Citations

1. jmir.org jmir.org/2024/1/e46036/

Effectiveness of an Artificial Intelligence-Assisted App for ... The primary outcomes were overeating habits, snacking habits, immediate thinking, self-regulation of eating habits, depression, anxiety, and ...

2. mdpi.com mdpi.com/1648-9144/61/2/358

The Role of Artificial Intelligence in Obesity Risk Prediction ... This narrative review explores the role of AI/ML in obesity risk prediction and management, with a special focus on childhood obesity.

3. withpower.com withpower.com/trial/phase-overweight-and-obesity-6-2024-59610

'Ai Pono for Obesity · Recruiting Participants ... A randomized controlled trial involving 340 participants showed that a digital lifestyle coaching program led to a significant weight loss of 4.5 kg over 12 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06526650

NCT06526650 | 'Ai Pono Cooking Demonstrations The objectives of this project are to optimize the effectiveness and sustainability of PILI 'Āina, improve diet quality, cardiometabolic markers, promote ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40609748/

Effectiveness of a digital weight management program on ... Secondary outcomes included percent weight loss and weight-loss milestones of 3%, 5%, and 10%. Intention-to-treat, 6-month differences ...

6. mdpi.com mdpi.com/2075-4418/15/3/396

Harnessing Artificial Intelligence in Obesity Research and ... AI, particularly ML and DL, is used in obesity research for risk prediction, early detection, and personalized treatment plans.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11857386/

The Role of Artificial Intelligence in Obesity Risk Prediction ... This narrative review explores the role of AI/ML in obesity risk prediction and management, with a special focus on childhood obesity.

8. pacifichealthdialog.nz pacifichealthdialog.nz/pre-2013-archive/Volume2011/no2/PHD1120220p2502025920Fujita20orig.pdf

The traditional Hawaiian diet: a review of the literature Native Hawaiians have higher rates of overweight and obesity than other ethnic groups in Hawai'i. In addition, the percentages of Native Hawaiians who are ...

9. news-medical.net news-medical.net/news/20251016/New-AI-tool-detects-bite-rate-to-help-prevent-childhood-obesity.aspx

New AI tool detects bite rate to help prevent childhood ... The faster a child takes bites during a meal or snack, the greater risk they have for developing obesity, according to researchers in the ...