Physical Activity for Insulin Resistance
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.
Will I have to stop taking my current medications?
If your child is taking medications like Metformin, GLP-1R Agonist, Insulin, or GnRH agonist, they cannot participate in the trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.
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.12345Why 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.16789
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Initial assessment including body composition, insulin dynamics, reproductive hormones, and physical activity
Full Intensity Intervention
Participants receive educational messaging and health coaching visits to support physical activity
Delayed Lower Intensity Intervention
Participants receive lower intensity educational messaging only
Follow-up
Participants are monitored for changes in physical activity, insulin sensitivity, and hormone levels
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?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Citations
ActiveGirls: Physical Activity, Hormone Health, and ...
Study Details | NCT07102797 | ActiveGirls: Physical Activity, Hormone Health, and Diabetes Risk in Early Adolescence | ClinicalTrials.gov.
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.
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 ...
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.
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-PositionPhysical 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).
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_AdolescentsModeration 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.
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