Physical Activity for Insulin Resistance

Overseen By Rachel Whooten, MD MPH

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Metformin, GLP-1R Agonist, Insulin, GnRH agonist

Disqualifiers: Diabetes, Endocrine, Androgen, Hyperthyroidism, others

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

Compensation: Varies

Number of Visits: 9

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a special physical activity program might improve hormone health and reduce diabetes risk in girls. It seeks to determine if the program can engage girls and their families to become more active and how this activity might influence diabetes risk markers and puberty hormones over a year. Participants will either receive the full ActiveGirls Physical Activity Program, which includes health coaching and educational messages, or receive educational messages only. The trial seeks girls aged 8-12 who are at risk for conditions like PCOS or insulin resistance, often due to family history or specific growth patterns. As an unphased trial, this study provides a unique opportunity for participants to contribute to understanding the impact of lifestyle changes on health.

What prior data suggests that the ActiveGirls Physical Activity Program is safe for girls ages 8-12?

Research shows that physical activity is generally safe and well-tolerated for most people, including young girls. Studies have found that exercise can help the body use insulin more effectively, which is especially beneficial for those at risk of diabetes.

The 'ActiveGirls' program includes both full-intensity and delayed lower-intensity activities, combining exercise with educational messages. Regular exercise, even at low intensity, has improved insulin use and addressed health issues like blood pressure and cholesterol levels without causing major problems.

These trials have not shown any significant safety concerns for the ActiveGirls program. Exercise programs like this are widely used and known to be safe. Participants in similar studies found exercise manageable and safe when done with proper guidance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to tackling insulin resistance through physical activity. Unlike standard treatments like medication or dietary changes, the ActiveGirls Physical Activity Program focuses on structured exercise and health coaching. The Full Intensity Intervention includes personalized coaching and frequent educational messages, which can motivate participants and set realistic activity goals. Meanwhile, the Delayed Lower Intensity group receives educational messages only, allowing researchers to compare the effects of added coaching. This trial aims to uncover how different levels of support and guidance in physical activity can impact insulin resistance, potentially offering a more engaging and proactive way to manage the condition.

What evidence suggests that the ActiveGirls Physical Activity Program could be effective for reducing diabetes risk in girls?

Studies have shown that physical activity can significantly improve insulin management and lower blood sugar levels in children and teens, especially those who are overweight. Research indicates that programs like 'Girls Active', which promote exercise, have successfully improved adolescent health. Regular exercise helps manage blood sugar and cholesterol levels and can lead to weight loss. In this trial, participants in the "Full Intensity Intervention" arm will receive the comprehensive ActiveGirls program, including educational messaging and health coaching. Meanwhile, the "Delayed Lower Intensity Comparison Group" will receive a lower intensity intervention with educational messaging only. Both versions of the ActiveGirls program could potentially lower the risk of diabetes in young girls. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

The ActiveGirls trial is for English-speaking girls aged 8-12 who haven't started menstruating and are at risk for PCOS/insulin resistance due to factors like high BMI, maternal history of PCOS/GDM, early puberty signs, or being small for gestational age. Caregivers must be able to receive texts or emails.

Inclusion Criteria

I am a caregiver of a child, speak English, and can receive study emails or texts.

I am a girl aged 8-12, at risk for PCOS/insulin resistance, and have not started menstruating.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment including body composition, insulin dynamics, reproductive hormones, and physical activity

1 day

1 visit (in-person)

Full Intensity Intervention

Participants receive educational messaging and health coaching visits to support physical activity

6 months

6 visits (in-person)

Delayed Lower Intensity Intervention

Participants receive lower intensity educational messaging only

6 months

Remote monitoring

Follow-up

Participants are monitored for changes in physical activity, insulin sensitivity, and hormone levels

12 months

2 visits (1 in-person, 1 remote)

What Are the Treatments Tested in This Trial?

Interventions

• ActiveGirls Physical Activity Program (Delayed Lower Intensity)
• ActiveGirls Physical Activity Program (Full)

Trial Overview This study tests how a physical activity program affects hormone health and diabetes risk in young girls. It compares a full intervention with coaching visits against a delayed lower intensity one using only educational messages over six months.

How Is the Trial Designed?

Group I: Full Intensity Intervention Experimental Treatment 1 Intervention

Participants in this arm will receive the 'full' intensive ActiveGirls intervention, which will include educational messaging (3-4/week, via email or text message) as well as a series of 6 health coaching visits for physical activity goal setting. Participants in this arm will receive the intervention in months 1-6 of their study participation.

Group II: Delayed lower intensity comparison group Active Control 1 Intervention

Participants in this arm will receive a lower intensity educational messaging only intervention in months 7-12 of their study participation. This group will not receive health coaching.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07102797

ActiveGirls: Physical Activity, Hormone Health, and ... Study Details | NCT07102797 | ActiveGirls: Physical Activity, Hormone Health, and Diabetes Risk in Early Adolescence | ClinicalTrials.gov.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5918764/

Effectiveness of the 'Girls Active' school-based physical ... Outcomes for the cost-consequence analysis were health related quality of life measured by the Child Health Utility-9D and service use. Results.

3. researchgate.net researchgate.net/publication/331393451_Physical_activity_and_the_level_of_HbA1c_in_children_and_adolescents_with_type_1_diabetes_mellitus

(PDF) Physical activity and the level of HbA1c in children ... ... fitness levels, although results ... physical activity improves glucose and lipid levels, reduces weight and improves insulin resistance.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8164651/

Effectiveness of Resistance Training and Associated ... Research has also demonstrated that RT can improve cardiometabolic outcomes, such as increased insulin sensitivity and improved glycemic control ...

5. physoc.onlinelibrary.wiley.com physoc.onlinelibrary.wiley.com/doi/10.14814/phy2.15540

Effect of after‐school physical activity on body composition in ... This study aimed to investigate the effect of a 24-month after-school physical activity intervention on body composition in normal-weight children.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8802999/

Exercise/Physical Activity in Individuals with Type 2 Diabetes Resistance exercise training in adults with T2D typically results in 10-15% improvements in strength, bone mineral density, blood pressure, lipid profiles, ...

7. diabetesjournals.org diabetesjournals.org/care/article/39/11/2065/37249/Physical-Activity-Exercise-and-Diabetes-A-Position

Physical Activity/Exercise and Diabetes: A Position Statement ... Even low-intensity aerobic exercise lasting ≥60 min enhances insulin action in obese, insulin-resistant adults for at least 24 h (53).

8. patlynk.com patlynk.com/trial/NCT01323088

Implications for Reversing Risk Factors for Type 2 Diabetes In this randomized controlled trial, we will examine the effect of a 3-month exercise training (aerobic exercise versus resistance exercise) without calorie ...

9. researchgate.net researchgate.net/publication/373031280_Moderation_of_Physical_Activity_between_Cardiometabolic_Risk_and_Adiponectin_in_Adolescents

Moderation of Physical Activity between Cardiometabolic ... We conclude that physical activity was a moderator in the relationship with adiposity, insulin resistance and sensitivity, LDL-c, and adiponectin.