This program measures dietary behaviors, clinical status, and potential behavior mediators through a nutrition education intervention for adults diagnosed with type 2 diabetes. The study is adapted from a primary health care setting and, again, in South Africa, at a tertiary health care setting. The hypothesis is the intervention will successfully lower HbA1c levels by at least 0.05% in six months. Additionally, researchers hypothesize HbA1c levels will be significantly lower in the intervention group than the control group.
The study is interventional (participants receive treatment, referred to as “interventions”), randomized (participants are chosen by chance for treatment), parallel (two groups receive two different forms of treatment) and double blind (neither the care provider nor the outcomes accessor knows the identity of the variable). It includes two arms and one intervention. An experimental intervention group arm and a no intervention control group arm will be utilized. The nutrition education intervention is behavioral. The HbA1C levels of participants are the measurements to be used in an attempt to reach the primary outcome.
To participate, interested persons must be living with type 1 diabetes for at least one year and regularly attended a diabetes clinic. Specifically, they need to be type 2 diabetics with poorly controlled health, indicated by an HbA1c level greater than eight percent. While participants are required to be mobile, they cannot have plans to leave the study site for at least a year.
If interested persons meet the inclusion criteria only two factors are listed in the excluded criteria that could have eliminated them. They cannot have any serious complications (further defined by investigators) and must be employed full-time.
The primary health care center of this study is the location of the sponsor, the University of Pretoria. To offer a valid comparison, the South African Sugar Association, will serve as the collaborator and provide the tertiary health care center. The main researcher is Jane Muchiri of the University of Pretoria.